## Protocol Section
### Identification Module
**NCT ID:** NCT02740179

**Brief Title:** Effects of Eplerenone on Cardiovascular Disease in HIV (MIRACLE HIV Study)

**Official Title:** Mineralocorticoid Receptor Antagonism for Cardiovascular Health in HIV--The MIRACLE HIV Study

#### Organization Study ID Info
**ID:** 2016P000464
#### Organization
**Class:** OTHER
**Full Name:** Massachusetts General Hospital
### Status Module
#### Completion Date
**Date:** 2022-03-17

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-06-06

**Type:** ACTUAL

**Last Update Submit Date:** 2023-06-02

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-03-17

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2023-06-02

**Type:** ACTUAL

**Results First Submit Date:** 2023-03-16

**Results First Submit QC Date:** 2023-05-04

#### Start Date
**Date:** 2017-01

**Status Verified Date:** 2023-06

#### Study First Post Date
**Date:** 2016-04-15
**Type:** ESTIMATED
**Study First Submit Date:** 2016-04-07
**Study First Submit QC Date:** 2016-04-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Massachusetts General Hospital

#### Responsible Party

**Investigator Affiliation:** Massachusetts General Hospital

**Investigator Full Name:** Steven K. Grinspoon, MD

**Investigator Title:** Professor of Medicine

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** HIV-infected individuals treated with antiretroviral medications are living longer, but have an increased risk of heart disease when compared to non-HIV-infected individuals. A hormone called aldosterone, which regulates blood pressure and sodium balance, is elevated in the HIV population in association with with increased belly fat and altered glucose metabolism. Elevations in aldosterone hormone may also be associated with abnormal blood flow, inflammation, and coronary plaque in the heart. This study is being conducted to evaluate whether therapies to reduce the actions of aldosterone may decrease the burden and progression of heart disease in the HIV population.

**Detailed Description:** This is a 12 month randomized, placebo controlled study enrolling HIV-infected individuals with no known history of cardiovascular disease. Eplerenone is a mineralocorticoid receptor antagonist, which can block aldosterone activation. This medication is approved by the FDA for high blood pressure and heart failure. This study aims to investigate the effect of eplerenone on other measures of cardiovascular disease in HIV. Using PET, MRI, and CT imaging technology, this study will evaluate whether eplerenone can improve coronary flow reserve and myocardial inflammation/fibrosis, in addition to atherosclerotic plaque build-up among the HIV population. The study also includes teaching on lifestyle modification to promote a healthy diet and exercise program.There are 3 overnight visits in addition to safety visits.

### Conditions Module

**Conditions:**

- HIV

**Keywords:**

- Eplerenone

- Cardiovascular Disease

- Mineralocorticoid Receptor Antagonist

- Coronary Vasculature

- Myocardial Inflammation

- Myocardial Fibrosis

- Atherosclerosis

- Aldosterone

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 40

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Eplerenone 50 mg twice daily along with lifestyle modification (counseling regarding diet and healthy activity) for 12 months

**Intervention Names:**

- Drug: Eplerenone

- Behavioral: Lifestyle Modification

**Label:** Eplerenone

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Placebo twice daily along with lifestyle modification (counseling regarding diet and healthy activity) for 12 months

**Intervention Names:**

- Drug: Placebo

- Behavioral: Lifestyle Modification

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Eplerenone

**Description:** Eplerenone 50mg by mouth twice daily

**Name:** Eplerenone

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Placebo

**Description:** Placebo by mouth twice daily

**Name:** Placebo

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Eplerenone

- Placebo

**Description:** Counseling regarding diet and healthy activity

**Name:** Lifestyle Modification

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** Change (value at 12 months minus value at baseline) in myocardial perfusion assessed by coronary flow reserve measured via cardiac positron emission tomography. Coronary flow reserve is given by the ratio of blood flow at stress during maximal dilation of the coronary arteries to blood flow at rest.

**Measure:** Myocardial Perfusion by PET

**Time Frame:** 12 Months

**Description:** Change (value at 12 months minus value at baseline) in myocardial perfusion assessed by myocardial blood flow measured via cardiac magnetic resonance imaging

**Measure:** Myocardial Perfusion by MRI

**Time Frame:** 12 Months

**Description:** Change (value at 12 months minus value at baseline) in myocardial inflammation measured by extracellular mass index (a measure of the inflammation within the heart) via cardiac magnetic resonance imaging

**Measure:** Myocardial Inflammation

**Time Frame:** 12 Months

#### Secondary Outcomes

**Description:** Change (value at 12 months minus value at baseline) in coronary plaque measured via coronary computed tomography angiogram assessed by coronary calcium score Scale: minimum 0 to maximum no limit, higher score indicates more plaque

**Measure:** Coronary Plaque

**Time Frame:** 12 Months

**Description:** Change (value at 12 months minus value at baseline) in serum hs-cTnT

**Measure:** Markers of Vascular Dysfunction

**Time Frame:** 12 Months

**Description:** Change (value at 12 months minus value at baseline) in plasma hsIL-6

**Measure:** Markers of Systemic Inflammation hsIL-6

**Time Frame:** 12 Months

**Description:** Change (value at 12 months minus value at baseline) in plasma hsCRP

**Measure:** Markers of Systemic Inflammation hsCRP

**Time Frame:** 12 Months

**Description:** Change (value at 12 months minus value at baseline) in plasma MCP-1

**Measure:** Markers of Immune Activation MCP-1

**Time Frame:** 12 Months

**Description:** Change (value at 12 months minus value at baseline) in plasma sCD163

**Measure:** Markers of Immune Activation sCD163

**Time Frame:** 12 Months

**Description:** Change (value at 12 months minus value at baseline) in serum NT-proBNP

**Measure:** Markers of Subclinical Injury

**Time Frame:** 12 Months

**Description:** Change (value at 12 months minus value at baseline) in myocardial fibrosis measured by T1 (a signal intensity that measures fibrosis) via cardiac magnetic resonance imaging

**Measure:** Markers of Fibrosis

**Time Frame:** 12 Months

**Description:** Percentage change (value at 12 months minus value at baseline) in target to background ratio (a measure of arterial inflammation) of the index vessel measured via positron emission tomography/computed tomography

**Measure:** Arterial Inflammation

**Time Frame:** 12 Months

**Description:** Change (value at 12 months minus value at baseline) in plasma LpPLA2

**Measure:** Markers of Arterial Inflammation

**Time Frame:** 12 Months

**Description:** Change (value at 12 months minus value at baseline) in left ventricular mass on cardiac magnetic resonance imaging

**Measure:** Assessment of Cardiac Structure by Left Ventricular Mass on Cardiac Imaging

**Time Frame:** 12 Months

**Description:** Change (value at 12 months minus value at baseline) in global circumferential strain (GCS) on cardiac magnetic resonance imaging

**Measure:** Assessment of Cardiac Systolic Function Via Cardiac Imaging

**Time Frame:** 12 Months

**Description:** Change (value at 12 months minus value at baseline) in left ventricular end diastolic volume on cardiac magnetic resonance imaging

**Measure:** Assessment of Cardiac Diastolic Function Via Cardiac Imaging

**Time Frame:** 12 Months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Ages 40-65 years
2. Antiretroviral use (ART) \>12 months and HIV viral load \<100 copies/mL
3. VAT\> 110cm2

Exclusion Criteria:

1. Antihypertensive use including, ACE Inhibitor, ARB, MR blockade, diuretic, potassium (K) supplementation; or BP\>140/90 mmHg. Stable use (\>3 months) of beta-blockers or calcium channel blockers (CCB) (except verapamil) is allowed.
2. Unstable statin use \<12 months. Stable use (\>12 months) is allowed.
3. Use of full dose ritonavir, nelfinavir, clarithromycin, and other strong inhibitors of CYP3A4, as well as CYP3A4 inducers.
4. Continuous oral steroid use (equivalent to prednisone \> 5 mg daily) within the last 3 months.
5. Uncontrolled diabetes requiring insulin and/or HbA1c \> 7.5%.
6. Creatinine (Cr) \> 1.5 mg/dL or estimated GFR\<60 mL/min/1.73m2.
7. K \> 5.5 mEq/L.
8. Hemoglobin \< 10 g/dL.
9. Known liver disease or ALT \>3x ULN.
10. History of congestive heart failure, stroke, myocardial infarction, or known coronary artery disease.
11. Pregnant, actively seeking pregnancy or breastfeeding.
12. Estrogen, progestin derivative, or other sex steroid use within last 3 months. Stable physiologic testosterone replacement (\> 3 months) is acceptable.
13. Current bacterial or other infections.
14. Active substance abuse.
15. Significant radiation exposure over the course of the year prior to randomization (e.g., radiation therapy, PCI, catheter ablation of arrhythmia) within 12 months of randomization.
16. Previous reaction or contraindication to iodine-containing contrast media and gadolinium.
17. Coronary artery luminal narrowing \>70% on coronary CTA.

**Maximum Age:** 65 Years

**Minimum Age:** 40 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Boston

**Country:** United States

**Facility:** Massachusetts General Hospital

**State:** Massachusetts

**Zip:** 02114

### References Module

#### References

**Citation:** Srinivasa S, Fitch KV, Wong K, Torriani M, Mayhew C, Stanley T, Lo J, Adler GK, Grinspoon SK. RAAS Activation Is Associated With Visceral Adiposity and Insulin Resistance Among HIV-infected Patients. J Clin Endocrinol Metab. 2015 Aug;100(8):2873-82. doi: 10.1210/jc.2015-1461. Epub 2015 Jun 18.

**PMID:** 26086328

## Document Section

### Large Document Module

#### Large Docs

- Date: 2022-11-08

- Filename: Prot_SAP_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol and Statistical Analysis Plan

- Size: 419403

- Type Abbrev: Prot_SAP

- Upload Date: 2023-03-09T13:37

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC01

- Name: Infections

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10293

- Name: Inflammation

- Relevance: LOW

- As Found: Unknown

- ID: M8485

- Name: Fibrosis

- Relevance: LOW

- As Found: Unknown

- ID: M3522

- Name: Acquired Immunodeficiency Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M18250

- Name: HIV Infections

- Relevance: LOW

- As Found: Unknown

- ID: M26188

- Name: Atherosclerosis

- Relevance: LOW

- As Found: Unknown

- ID: M12157

- Name: Myocarditis

- Relevance: LOW

- As Found: Unknown

- ID: T4005

- Name: Myocarditis

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002318

- Term: Cardiovascular Diseases

### Intervention Browse Module - Ancestors

- ID: D000000451

- Term: Mineralocorticoid Receptor Antagonists

- ID: D000006727

- Term: Hormone Antagonists

- ID: D000006730

- Term: Hormones, Hormone Substitutes, and Hormone Antagonists

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000062865

- Term: Diuretics, Potassium Sparing

- ID: D000004232

- Term: Diuretics

- ID: D000045283

- Term: Natriuretic Agents

- ID: D000000959

- Term: Antihypertensive Agents

### Intervention Browse Module - Browse Branches

- Abbrev: AnAg

- Name: Antihypertensive Agents

- Abbrev: NaAg

- Name: Natriuretic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M1823

- Name: Eplerenone

- Relevance: HIGH

- As Found: Everyday

- ID: M3797

- Name: Mineralocorticoid Receptor Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M11871

- Name: Mineralocorticoids

- Relevance: LOW

- As Found: Unknown

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M9788

- Name: Hormone Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M7411

- Name: Diuretics

- Relevance: LOW

- As Found: Unknown

- ID: M30025

- Name: Diuretics, Potassium Sparing

- Relevance: LOW

- As Found: Unknown

- ID: M4277

- Name: Antihypertensive Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000077545

- Term: Eplerenone

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Eplerenone

**Deaths Num Affected:** 1

**Deaths Num At Risk:** 20

**Description:** Eplerenone 50 mg twice daily along with lifestyle modification (counseling regarding diet and healthy activity) for 12 months

Eplerenone: Eplerenone 50mg by mouth twice daily

Lifestyle Modification: Counseling regarding diet and healthy activity

**ID:** EG000

**Other Num Affected:** 12

**Other Num at Risk:** 20

**Serious Number Affected:** 1

**Serious Number At Risk:** 20

**Title:** Eplerenone

**Group ID:** EG001

**Title:** Placebo

**Deaths Num At Risk:** 20

**Description:** Placebo twice daily along with lifestyle modification (counseling regarding diet and healthy activity) for 12 months

Placebo: Placebo by mouth twice daily

Lifestyle Modification: Counseling regarding diet and healthy activity

**ID:** EG001

**Other Num Affected:** 11

**Other Num at Risk:** 20

**Serious Number At Risk:** 20

**Title:** Placebo

**Frequency Threshold:** 5

#### Other Events

**Term:** Dizziness

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** 

**Term:** Gastrointestinal Symptoms

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Rash

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** 

**Term:** Upper Respiratory Infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** 

**Term:** Other Infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** 

**Term:** Musculoskeletal Pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** 

**Term:** Cardiovascular Symptoms

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** 

**Term:** Injuries

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** 

**Term:** Other Respiratory Symptoms

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** 

**Term:** Urinary Volume Increase

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** 

**Term:** Underwent Non-Cardiac Elective Procedure

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Surgical and medical procedures

**Source Vocabulary:** 

#### Serious Events

**Term:** Medical condition leading to death

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Notes:** Unrelated to study medication

**Organ System:** Social circumstances

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 20

**Group ID:** EG001

**Num At Risk:** 20

**Time Frame:** 12 Months

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 20

**Group ID:** BG001

**Value:** 20

**Group ID:** BG002

**Value:** 40

**Units:** Participants

### Group

**ID:** BG000

**Title:** Eplerenone

**Description:** Eplerenone 50 mg twice daily along with lifestyle modification (counseling regarding diet and healthy activity) for 12 months

Eplerenone: Eplerenone 50mg by mouth twice daily

Lifestyle Modification: Counseling regarding diet and healthy activity

### Group

**ID:** BG001

**Title:** Placebo

**Description:** Placebo twice daily along with lifestyle modification (counseling regarding diet and healthy activity) for 12 months

Placebo: Placebo by mouth twice daily

Lifestyle Modification: Counseling regarding diet and healthy activity

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 7

**Value:** 53

#### Measurement

**Group ID:** BG001

**Spread:** 6

**Value:** 56

#### Measurement

**Group ID:** BG002

**Spread:** 7

**Value:** 55

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 5

#### Measurement

**Group ID:** BG001

**Value:** 5

#### Measurement

**Group ID:** BG002

**Value:** 10

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 15

#### Measurement

**Group ID:** BG001

**Value:** 15

#### Measurement

**Group ID:** BG002

**Value:** 30

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 5

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 7

**Category Title:** Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 15

#### Measurement

**Group ID:** BG001

**Value:** 18

#### Measurement

**Group ID:** BG002

**Value:** 33

**Category Title:** Not Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** American Indian or Alaska Native

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Native Hawaiian or Other Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 5

#### Measurement

**Group ID:** BG001

**Value:** 6

#### Measurement

**Group ID:** BG002

**Value:** 11

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 11

#### Measurement

**Group ID:** BG001

**Value:** 11

#### Measurement

**Group ID:** BG002

**Value:** 22

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 1

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 4

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 6

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 20

#### Measurement

**Group ID:** BG001

**Value:** 20

#### Measurement

**Group ID:** BG002

**Value:** 40

**Class Title:** United States

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Ethnicity (NIH/OMB)
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
### Measure 5
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
## Results Section - More Information Module
### Certain Agreement
### Point of Contact
**Email:** sgrinspoon@mgh.harvard.edu
**Organization:** Massachusetts General Hospital
**Phone:** 617-724-9109
**Title:** Dr. Steven K. Grinspoon
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.72
**P-Value Comment:** P value for Change in Coronary Flow Reserve on Cardiac PET
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** t-test, 2 sided
**Tested Non-Inferiority:** 
### Outcome Measure 2
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.03
**P-Value Comment:** P value for Change in Stress Myocardial Blood Flow on Cardiac MRI
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** t-test, 2 sided
**Tested Non-Inferiority:** 
### Outcome Measure 3
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.38
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Kruskal-Wallis
**Tested Non-Inferiority:** 
### Outcome Measure 4
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.09
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Kruskal-Wallis
**Tested Non-Inferiority:** 
### Outcome Measure 5
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.03
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** Analyses performed on log transformation of data
**Statistical Method:** t-test, 2 sided
**Tested Non-Inferiority:** 
### Outcome Measure 6
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.09
**P-Value Comment:** P value for Change in Plasma IL-6
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** Analyses performed after log transformation of data
**Statistical Method:** t-test, 2 sided
**Tested Non-Inferiority:** 
### Outcome Measure 7
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.36
**P-Value Comment:** P value for Change in Plasma hsCRP
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** Analyses performed after log transformation of data
**Statistical Method:** t-test, 2 sided
**Tested Non-Inferiority:** 
### Outcome Measure 8
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.88
**P-Value Comment:** P value for Change in Plasma MCP-1
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** Analyses performed after log transformation of data
**Statistical Method:** t-test, 2 sided
**Tested Non-Inferiority:** 
### Outcome Measure 9
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.17
**P-Value Comment:** P value for Change in Plasma sCD163
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** Analyses performed after log transformation of data
**Statistical Method:** t-test, 2 sided
**Tested Non-Inferiority:** 
### Outcome Measure 10
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.28
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** Analyses performed after log transformation of data
**Statistical Method:** t-test, 2 sided
**Tested Non-Inferiority:** 
### Outcome Measure 11
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.32
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Kruskal-Wallis
**Tested Non-Inferiority:** 
### Outcome Measure 12
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.003
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Kruskal-Wallis
**Tested Non-Inferiority:** 
### Outcome Measure 13
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.73
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Kruskal-Wallis
**Tested Non-Inferiority:** 
### Outcome Measure 14
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.56
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Kruskal-Wallis
**Tested Non-Inferiority:** 
### Outcome Measure 15
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.03
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Kruskal-Wallis
**Tested Non-Inferiority:** 
### Outcome Measure 16
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.03
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** t-test, 2 sided
**Tested Non-Inferiority:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.64
- **Upper Limit:** 
- **Value:** 0.01
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.48
- **Upper Limit:** 
- **Value:** -0.07
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.56
- **Upper Limit:** 
- **Value:** 0.09
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.68
- **Upper Limit:** 
- **Value:** -0.53
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -2.3
- **Spread:** 
- **Upper Limit:** 4.3
- **Value:** 0.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -2.2
- **Spread:** 
- **Upper Limit:** -0.1
- **Value:** -0.7
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 6
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 41
- **Value:** 5
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -0.13
- **Spread:** 
- **Upper Limit:** 0.00
- **Value:** 0.00
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.00
- **Spread:** 
- **Upper Limit:** 0.74
- **Value:** 0.00
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -1.8
- **Spread:** 
- **Upper Limit:** 0.4
- **Value:** -0.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -0.5
- **Spread:** 
- **Upper Limit:** 2.2
- **Value:** 0.2
**Title:** 
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -3841
- **Spread:** 
- **Upper Limit:** 718
- **Value:** 189
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -261
- **Spread:** 
- **Upper Limit:** 2346
- **Value:** 591
**Title:** 
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 49
- **Spread:** 
- **Upper Limit:** 365
- **Value:** 285
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 241
- **Spread:** 
- **Upper Limit:** 352
- **Value:** 292
**Title:** 
#### Outcome Measure 9
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -384
- **Spread:** 
- **Upper Limit:** -11
- **Value:** -275
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -304
- **Spread:** 
- **Upper Limit:** 100
- **Value:** -160
**Title:** 
#### Outcome Measure 10
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 6.6
- **Spread:** 
- **Upper Limit:** 41.0
- **Value:** 19.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -25.6
- **Spread:** 
- **Upper Limit:** 63.5
- **Value:** 2.8
**Title:** 
#### Outcome Measure 11
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 5
- **Spread:** 
- **Upper Limit:** 74
- **Value:** 25
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -50
- **Spread:** 
- **Upper Limit:** 85
- **Value:** 1
**Title:** 
#### Outcome Measure 12
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -21.9
- **Spread:** 
- **Upper Limit:** -2.6
- **Value:** -12.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -1.6
- **Spread:** 
- **Upper Limit:** 11.0
- **Value:** 5.1
**Title:** 
#### Outcome Measure 13
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -6.6
- **Spread:** 
- **Upper Limit:** 25.0
- **Value:** 3.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -10.1
- **Spread:** 
- **Upper Limit:** 9.5
- **Value:** 2.6
**Title:** 
#### Outcome Measure 14
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -25
- **Spread:** 
- **Upper Limit:** 26
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -3
- **Spread:** 
- **Upper Limit:** 17
- **Value:** 9
**Title:** 
#### Outcome Measure 15
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -2.9
- **Spread:** 
- **Upper Limit:** 1.0
- **Value:** -1.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -0.4
- **Spread:** 
- **Upper Limit:** 4.1
- **Value:** 2.3
**Title:** 
#### Outcome Measure 16
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 28
- **Upper Limit:** 
- **Value:** -13
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 26
- **Upper Limit:** 
- **Value:** 10
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Change (value at 12 months minus value at baseline) in myocardial perfusion assessed by coronary flow reserve measured via cardiac positron emission tomography. Coronary flow reserve is given by the ratio of blood flow at stress during maximal dilation of the coronary arteries to blood flow at rest.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Analyses performed on data available
**Reporting Status:** POSTED
**Time Frame:** 12 Months
**Title:** Myocardial Perfusion by PET
**Type:** PRIMARY
**Unit of Measure:** unitless
##### Group
**Description:** Eplerenone 50 mg twice daily along with lifestyle modification (counseling regarding diet and healthy activity) for 12 months

Eplerenone: Eplerenone 50mg by mouth twice daily

Lifestyle Modification: Counseling regarding diet and healthy activity
**ID:** OG000
**Title:** Eplerenone
##### Group
**Description:** Placebo twice daily along with lifestyle modification (counseling regarding diet and healthy activity) for 12 months

Placebo: Placebo by mouth twice daily

Lifestyle Modification: Counseling regarding diet and healthy activity
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 2
**Description:** Change (value at 12 months minus value at baseline) in myocardial perfusion assessed by myocardial blood flow measured via cardiac magnetic resonance imaging
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Analyses performed on data available
**Reporting Status:** POSTED
**Time Frame:** 12 Months
**Title:** Myocardial Perfusion by MRI
**Type:** PRIMARY
**Unit of Measure:** mL/min/g
##### Group
**Description:** Eplerenone 50 mg twice daily along with lifestyle modification (counseling regarding diet and healthy activity) for 12 months

Eplerenone: Eplerenone 50mg by mouth twice daily

Lifestyle Modification: Counseling regarding diet and healthy activity
**ID:** OG000
**Title:** Eplerenone
##### Group
**Description:** Placebo twice daily along with lifestyle modification (counseling regarding diet and healthy activity) for 12 months

Placebo: Placebo by mouth twice daily

Lifestyle Modification: Counseling regarding diet and healthy activity
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 3
**Description:** Change (value at 12 months minus value at baseline) in myocardial inflammation measured by extracellular mass index (a measure of the inflammation within the heart) via cardiac magnetic resonance imaging
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Population Description:** Analyses performed on data available
**Reporting Status:** POSTED
**Time Frame:** 12 Months
**Title:** Myocardial Inflammation
**Type:** PRIMARY
**Unit of Measure:** g/m^2
##### Group
**Description:** Eplerenone 50 mg twice daily along with lifestyle modification (counseling regarding diet and healthy activity) for 12 months

Eplerenone: Eplerenone 50mg by mouth twice daily

Lifestyle Modification: Counseling regarding diet and healthy activity
**ID:** OG000
**Title:** Eplerenone
##### Group
**Description:** Placebo twice daily along with lifestyle modification (counseling regarding diet and healthy activity) for 12 months

Placebo: Placebo by mouth twice daily

Lifestyle Modification: Counseling regarding diet and healthy activity
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 4
**Description:** Change (value at 12 months minus value at baseline) in coronary plaque measured via coronary computed tomography angiogram assessed by coronary calcium score Scale: minimum 0 to maximum no limit, higher score indicates more plaque
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Population Description:** Analyses performed on data available
**Reporting Status:** POSTED
**Time Frame:** 12 Months
**Title:** Coronary Plaque
**Type:** SECONDARY
**Unit of Measure:** score on a scale
##### Group
**Description:** Eplerenone 50 mg twice daily along with lifestyle modification (counseling regarding diet and healthy activity) for 12 months

Eplerenone: Eplerenone 50mg by mouth twice daily

Lifestyle Modification: Counseling regarding diet and healthy activity
**ID:** OG000
**Title:** Eplerenone
##### Group
**Description:** Placebo twice daily along with lifestyle modification (counseling regarding diet and healthy activity) for 12 months

Placebo: Placebo by mouth twice daily

Lifestyle Modification: Counseling regarding diet and healthy activity
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 5
**Description:** Change (value at 12 months minus value at baseline) in serum hs-cTnT
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Population Description:** Analyses performed on data available
**Reporting Status:** POSTED
**Time Frame:** 12 Months
**Title:** Markers of Vascular Dysfunction
**Type:** SECONDARY
**Unit of Measure:** ng/L
##### Group
**Description:** Eplerenone 50 mg twice daily along with lifestyle modification (counseling regarding diet and healthy activity) for 12 months

Eplerenone: Eplerenone 50mg by mouth twice daily

Lifestyle Modification: Counseling regarding diet and healthy activity
**ID:** OG000
**Title:** Eplerenone
##### Group
**Description:** Placebo twice daily along with lifestyle modification (counseling regarding diet and healthy activity) for 12 months

Placebo: Placebo by mouth twice daily

Lifestyle Modification: Counseling regarding diet and healthy activity
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 6
**Description:** Change (value at 12 months minus value at baseline) in plasma hsIL-6
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Population Description:** Analyses performed on data available
**Reporting Status:** POSTED
**Time Frame:** 12 Months
**Title:** Markers of Systemic Inflammation hsIL-6
**Type:** SECONDARY
**Unit of Measure:** pg/mL
##### Group
**Description:** Eplerenone 50 mg twice daily along with lifestyle modification (counseling regarding diet and healthy activity) for 12 months

Eplerenone: Eplerenone 50mg by mouth twice daily

Lifestyle Modification: Counseling regarding diet and healthy activity
**ID:** OG000
**Title:** Eplerenone
##### Group
**Description:** Placebo twice daily along with lifestyle modification (counseling regarding diet and healthy activity) for 12 months

Placebo: Placebo by mouth twice daily

Lifestyle Modification: Counseling regarding diet and healthy activity
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 7
**Description:** Change (value at 12 months minus value at baseline) in plasma hsCRP
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Population Description:** Analyses performed on data available
**Reporting Status:** POSTED
**Time Frame:** 12 Months
**Title:** Markers of Systemic Inflammation hsCRP
**Type:** SECONDARY
**Unit of Measure:** ng/mL
##### Group
**Description:** Eplerenone 50 mg twice daily along with lifestyle modification (counseling regarding diet and healthy activity) for 12 months

Eplerenone: Eplerenone 50mg by mouth twice daily

Lifestyle Modification: Counseling regarding diet and healthy activity
**ID:** OG000
**Title:** Eplerenone
##### Group
**Description:** Placebo twice daily along with lifestyle modification (counseling regarding diet and healthy activity) for 12 months

Placebo: Placebo by mouth twice daily

Lifestyle Modification: Counseling regarding diet and healthy activity
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 8
**Description:** Change (value at 12 months minus value at baseline) in plasma MCP-1
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Population Description:** Analyses performed on data available
**Reporting Status:** POSTED
**Time Frame:** 12 Months
**Title:** Markers of Immune Activation MCP-1
**Type:** SECONDARY
**Unit of Measure:** pg/mL
##### Group
**Description:** Eplerenone 50 mg twice daily along with lifestyle modification (counseling regarding diet and healthy activity) for 12 months

Eplerenone: Eplerenone 50mg by mouth twice daily

Lifestyle Modification: Counseling regarding diet and healthy activity
**ID:** OG000
**Title:** Eplerenone
##### Group
**Description:** Placebo twice daily along with lifestyle modification (counseling regarding diet and healthy activity) for 12 months

Placebo: Placebo by mouth twice daily

Lifestyle Modification: Counseling regarding diet and healthy activity
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 9
**Description:** Change (value at 12 months minus value at baseline) in plasma sCD163
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Population Description:** Analyses performed on data available
**Reporting Status:** POSTED
**Time Frame:** 12 Months
**Title:** Markers of Immune Activation sCD163
**Type:** SECONDARY
**Unit of Measure:** ng/mL
##### Group
**Description:** Eplerenone 50 mg twice daily along with lifestyle modification (counseling regarding diet and healthy activity) for 12 months

Eplerenone: Eplerenone 50mg by mouth twice daily

Lifestyle Modification: Counseling regarding diet and healthy activity
**ID:** OG000
**Title:** Eplerenone
##### Group
**Description:** Placebo twice daily along with lifestyle modification (counseling regarding diet and healthy activity) for 12 months

Placebo: Placebo by mouth twice daily

Lifestyle Modification: Counseling regarding diet and healthy activity
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 10
**Description:** Change (value at 12 months minus value at baseline) in serum NT-proBNP
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Population Description:** Analyses performed on data available
**Reporting Status:** POSTED
**Time Frame:** 12 Months
**Title:** Markers of Subclinical Injury
**Type:** SECONDARY
**Unit of Measure:** ng/L
##### Group
**Description:** Eplerenone 50 mg twice daily along with lifestyle modification (counseling regarding diet and healthy activity) for 12 months

Eplerenone: Eplerenone 50mg by mouth twice daily

Lifestyle Modification: Counseling regarding diet and healthy activity
**ID:** OG000
**Title:** Eplerenone
##### Group
**Description:** Placebo twice daily along with lifestyle modification (counseling regarding diet and healthy activity) for 12 months

Placebo: Placebo by mouth twice daily

Lifestyle Modification: Counseling regarding diet and healthy activity
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 11
**Description:** Change (value at 12 months minus value at baseline) in myocardial fibrosis measured by T1 (a signal intensity that measures fibrosis) via cardiac magnetic resonance imaging
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Population Description:** Analyses performed on data available
**Reporting Status:** POSTED
**Time Frame:** 12 Months
**Title:** Markers of Fibrosis
**Type:** SECONDARY
**Unit of Measure:** ms
##### Group
**Description:** Eplerenone 50 mg twice daily along with lifestyle modification (counseling regarding diet and healthy activity) for 12 months

Eplerenone: Eplerenone 50mg by mouth twice daily

Lifestyle Modification: Counseling regarding diet and healthy activity
**ID:** OG000
**Title:** Eplerenone
##### Group
**Description:** Placebo twice daily along with lifestyle modification (counseling regarding diet and healthy activity) for 12 months

Placebo: Placebo by mouth twice daily

Lifestyle Modification: Counseling regarding diet and healthy activity
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 12
**Description:** Percentage change (value at 12 months minus value at baseline) in target to background ratio (a measure of arterial inflammation) of the index vessel measured via positron emission tomography/computed tomography
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Population Description:** Analyses performed on data available as part of a substudy.
**Reporting Status:** POSTED
**Time Frame:** 12 Months
**Title:** Arterial Inflammation
**Type:** SECONDARY
**Unit of Measure:** percentage change
##### Group
**Description:** Eplerenone 50 mg twice daily along with lifestyle modification (counseling regarding diet and healthy activity) for 12 months

Eplerenone: Eplerenone 50mg by mouth twice daily

Lifestyle Modification: Counseling regarding diet and healthy activity
**ID:** OG000
**Title:** Eplerenone
##### Group
**Description:** Placebo twice daily along with lifestyle modification (counseling regarding diet and healthy activity) for 12 months

Placebo: Placebo by mouth twice daily

Lifestyle Modification: Counseling regarding diet and healthy activity
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 13
**Description:** Change (value at 12 months minus value at baseline) in plasma LpPLA2
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Population Description:** Analyses performed on data available as part of a substudy.
**Reporting Status:** POSTED
**Time Frame:** 12 Months
**Title:** Markers of Arterial Inflammation
**Type:** SECONDARY
**Unit of Measure:** ng/mL
##### Group
**Description:** Eplerenone 50 mg twice daily along with lifestyle modification (counseling regarding diet and healthy activity) for 12 months

Eplerenone: Eplerenone 50mg by mouth twice daily

Lifestyle Modification: Counseling regarding diet and healthy activity
**ID:** OG000
**Title:** Eplerenone
##### Group
**Description:** Placebo twice daily along with lifestyle modification (counseling regarding diet and healthy activity) for 12 months

Placebo: Placebo by mouth twice daily

Lifestyle Modification: Counseling regarding diet and healthy activity
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 14
**Description:** Change (value at 12 months minus value at baseline) in left ventricular mass on cardiac magnetic resonance imaging
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Population Description:** Analyses performed on data available
**Reporting Status:** POSTED
**Time Frame:** 12 Months
**Title:** Assessment of Cardiac Structure by Left Ventricular Mass on Cardiac Imaging
**Type:** SECONDARY
**Unit of Measure:** g
##### Group
**Description:** Eplerenone 50 mg twice daily along with lifestyle modification (counseling regarding diet and healthy activity) for 12 months

Eplerenone: Eplerenone 50mg by mouth twice daily

Lifestyle Modification: Counseling regarding diet and healthy activity
**ID:** OG000
**Title:** Eplerenone
##### Group
**Description:** Placebo twice daily along with lifestyle modification (counseling regarding diet and healthy activity) for 12 months

Placebo: Placebo by mouth twice daily

Lifestyle Modification: Counseling regarding diet and healthy activity
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 15
**Description:** Change (value at 12 months minus value at baseline) in global circumferential strain (GCS) on cardiac magnetic resonance imaging
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Population Description:** Analyses performed on data available
**Reporting Status:** POSTED
**Time Frame:** 12 Months
**Title:** Assessment of Cardiac Systolic Function Via Cardiac Imaging
**Type:** SECONDARY
**Unit of Measure:** percentage GCS
##### Group
**Description:** Eplerenone 50 mg twice daily along with lifestyle modification (counseling regarding diet and healthy activity) for 12 months

Eplerenone: Eplerenone 50mg by mouth twice daily

Lifestyle Modification: Counseling regarding diet and healthy activity
**ID:** OG000
**Title:** Eplerenone
##### Group
**Description:** Placebo twice daily along with lifestyle modification (counseling regarding diet and healthy activity) for 12 months

Placebo: Placebo by mouth twice daily

Lifestyle Modification: Counseling regarding diet and healthy activity
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 16
**Description:** Change (value at 12 months minus value at baseline) in left ventricular end diastolic volume on cardiac magnetic resonance imaging
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** 12 Months
**Title:** Assessment of Cardiac Diastolic Function Via Cardiac Imaging
**Type:** SECONDARY
**Unit of Measure:** mL
##### Group
**Description:** Eplerenone 50 mg twice daily along with lifestyle modification (counseling regarding diet and healthy activity) for 12 months

Eplerenone: Eplerenone 50mg by mouth twice daily

Lifestyle Modification: Counseling regarding diet and healthy activity
**ID:** OG000
**Title:** Eplerenone
##### Group
**Description:** Placebo twice daily along with lifestyle modification (counseling regarding diet and healthy activity) for 12 months

Placebo: Placebo by mouth twice daily

Lifestyle Modification: Counseling regarding diet and healthy activity
**ID:** OG001
**Title:** Placebo
### Participant Flow Module
#### Group
**Description:** Eplerenone 50 mg twice daily along with lifestyle modification (counseling regarding diet and healthy activity) for 12 months

Eplerenone: Eplerenone 50mg by mouth twice daily

Lifestyle Modification: Counseling regarding diet and healthy activity
**ID:** FG000
**Title:** Eplerenone
#### Group
**Description:** Placebo twice daily along with lifestyle modification (counseling regarding diet and healthy activity) for 12 months

Placebo: Placebo by mouth twice daily

Lifestyle Modification: Counseling regarding diet and healthy activity
**ID:** FG001
**Title:** Placebo
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 20
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 20
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 14
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 19
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 6
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 1
**Has Results:** True