## Protocol Section
### Identification Module
**NCT ID:** NCT06425848

**Acronym:** HF2 Registry

**Brief Title:** HF2 Registry - Hemodynamic Frontiers in Heart Failure Registry

**Official Title:** Hemodynamic Frontiers in Heart Failure Registry

#### Organization Study ID Info
**ID:** STUDY00147383
#### Organization
**Class:** OTHER
**Full Name:** University of Kansas Medical Center
### Status Module
#### Completion Date
**Date:** 2030-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2030-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2022-10-21

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-02-29
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Kansas Medical Center

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of the HF2 (Hemodynamic Frontiers in Heart Failure) registry is to collect relevant patient-level demographic, clinical, laboratory, and hemodynamic data from patients implanted with pulmonary artery pressure sensor at participating centers to advance scientific knowledge about ambulatory hemodynamics monitoring and HF (Heart Failure) therapies. The data collected will be used for retrospective studies, quality improvement, identifying research cohorts, and member-initiated research.

**Detailed Description:** Longitudinal, multi-center, and non-interventional registry. Patients will be identified as eligible for pulmonary artery pressure sensor implant by a heart failure cardiologist from the heart failure clinic. They will consent for device implant and procedure (right heart catheterization) per standard of care. Patients may also consent to the registry participation, which is optional. They will be informed that the registry intends to gather data and that they may be approached in the future for additional research based on their data and clinical situation. Additionally, patients who underwent pulmonary artery pressure sensor implantation from January 1, 2019, will be identified and consent will be obtained for registry participation, which is optional.

### Conditions Module

**Conditions:**

- Heart Failure

**Keywords:**

- Pulmonary Artery (PA) pressure monitor

### Design Module

#### Design Info

**Observational Model:** OTHER

**Time Perspective:** OTHER

#### Enrollment Info

**Count:** 2000

**Type:** ESTIMATED

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 3 Years

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients who underwent PA pressure implantation from January 1, 2019 will be identified for registry participation. Patients who were implanted before November 8, 2022 will be considered enrolled in the retrospective arm of the registry and may not need to consent if consent waiver is granted by the institutional IRB (Institutional Review Board).

**Intervention Names:**

- Device: Observational

**Label:** Retrospective arm

#### Arm Group 2

**Description:** Patients will be identified as eligible for PA pressure sensor implant by a heart failure cardiologist. Patients will consent for device implant and procedure (right heart catheterization) as per standard of care. Patients may also consent to registry participation as per local institutional guidelines and requirements.

**Intervention Names:**

- Device: Observational

**Label:** Prospective arm

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Prospective arm

- Retrospective arm

**Description:** We are collecting information for both retrospective and prospective arm to further understand the utility of PA pressure sensors.

**Name:** Observational

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Hemodynamic data such as mean PA pressure in mmHg, PA systolic pressure in mmHg, PA diastolic pressures in mmHg, will be collected at the time of implant of PA pressure sensor and at 3 months, 6 months, 12 months, 24 months and 36 months post implant.

**Measure:** Change in hemodynamics

**Time Frame:** at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant.

**Description:** Echo data such as Left Ventricular Ejection Fraction (LVEF) percentage will be collected at implant and at 3 months, 6 months, 12 months, 24 months and 36 months if available.

**Measure:** Changes in Echocardiogram (ECHO)

**Time Frame:** at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant

**Description:** Medications changes such as type of diuretics, will be collected after implant and at 3 months, 6 months, 12 month, 24 months and 36 months. We are not collecting any doses or frequencies.

**Measure:** Medication changes

**Time Frame:** at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant

**Description:** Sodium levels, reported as millimoles per liter (mmol/L), will be collected at implant and 3 months, 6 months, 12 months, 24 months and 36 months post implant.

**Measure:** Sodium

**Time Frame:** at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant

**Description:** Potassium level, reported as milliequivalents per liter (mEq/L), will be collected at implant and 3 months, 6 months, 12 months, 24 months and 36 months post implant.

**Measure:** Potassium

**Time Frame:** at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant

**Description:** Hemoglobin concentration (Hb) reported as grams of hemoglobin per deciliter of blood (g/dL). Labs will be collected at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant

**Measure:** Hemoglobin

**Time Frame:** at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant

**Description:** BNP level, reported as 100 picograms per milliliter (pg/mL), will be collected at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant

**Measure:** B-type natriuretic peptide (BNP)

**Time Frame:** at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant

**Description:** NT-proBNP level, reported as 100 picograms per milliliter (pg/mL), will be collected at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant

**Measure:** aminoterminal pro B-type natriuretic peptide (NT-proBNP)

**Time Frame:** at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. All patients would have been or will be implanted per indications from FDA approval/CHAMPION trial. These would be patients with NYHA (New York Heart Association) Class III heart failure who had a prior hospitalization.
2. Patients who meet the expanded FDA indication (BNP elevation without hospitalization or NYHA class II).

Exclusion Criteria:

1. Patients less than 18 years of age.
2. Pregnant women at the scheduled time of PA pressure sensor implant.
3. Patients unable or unwilling to have continuity of care in the heart failure clinic.

**Maximum Age:** 100 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** All patients who have been or will be implanted with PA pressure sensor.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** kmunshi@kumc.edu

**Name:** Kartik Munshi, MPH

**Phone:** 913-945-6445

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** La Jolla

**Contacts:**

***Contact 1:***

- **Name:** Timothy Jordan, MD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Thomas Heywood, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** Scripps Health

**State:** California

**Status:** RECRUITING

**Zip:** 92037

**Location 2:**

**City:** Bloomington

**Contacts:**

***Contact 1:***

- **Name:** Maya Guglin, MD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Maya Guglin, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** Indiana University

**State:** Indiana

**Status:** RECRUITING

**Zip:** 47401

**Location 3:**

**City:** Kansas City

**Contacts:**

***Contact 1:***

- **Email:** kmunshi@kumc.edu

- **Name:** Kartik Munshi, MPH

- **Role:** CONTACT

***Contact 2:***

- **Name:** Hirak Shah, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** University of Kansas Medical Center

**State:** Kansas

**Status:** RECRUITING

**Zip:** 66160

**Location 4:**

**City:** Maplewood

**Contacts:**

***Contact 1:***

- **Name:** Terrie-Ann Benjamin, MD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Terrie-Ann Benjamin, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** Fairview Health

**State:** Minnesota

**Status:** NOT_YET_RECRUITING

**Zip:** 55109

**Location 5:**

**City:** Minneapolis

**Contacts:**

***Contact 1:***

- **Name:** Sarah Schwager, RN

- **Role:** CONTACT

***Contact 2:***

- **Name:** Mosi Bennett, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** Minneapolis Heart Institute Foundation/ Allina Health

**State:** Minnesota

**Status:** RECRUITING

**Zip:** 55407

**Location 6:**

**City:** Kansas City

**Contacts:**

***Contact 1:***

- **Name:** Timothy Fendler, MD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Timothy Fendler, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** Saint Luke's Health System

**State:** Missouri

**Status:** RECRUITING

**Zip:** 64131

**Location 7:**

**City:** Raleigh

**Contacts:**

***Contact 1:***

- **Name:** Elizabeth Volz, MD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Elizabeth Volz, MS

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** University of North Carolina/ Rex Hospital, Inc.

**State:** North Carolina

**Status:** RECRUITING

**Zip:** 27607

**Location 8:**

**City:** Portland

**Contacts:**

***Contact 1:***

- **Name:** Christy Lenhart, RN

- **Role:** CONTACT

***Contact 2:***

- **Name:** Jacob Abraham, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** Providence Heart Institute

**State:** Oregon

**Status:** RECRUITING

**Zip:** 97225

**Location 9:**

**City:** Columbia

**Contacts:**

***Contact 1:***

- **Name:** Suzanne Amaker

- **Role:** CONTACT

***Contact 2:***

- **Name:** Patrick McCann, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** Prisma Health

**State:** South Carolina

**Status:** RECRUITING

**Zip:** 29203

**Location 10:**

**City:** Sioux Falls

**Contacts:**

***Contact 1:***

- **Name:** Orvaar Jonsson, MD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Orvaar Jonsson, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** Sanford Health

**State:** South Dakota

**Status:** RECRUITING

**Zip:** 57104

**Location 11:**

**City:** Austin

**Contacts:**

***Contact 1:***

- **Name:** Kunjan Bhatt, MS

- **Role:** CONTACT

***Contact 2:***

- **Name:** Kunjan Bhatt, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** Austin Heart

**State:** Texas

**Status:** RECRUITING

**Zip:** 78756

**Location 12:**

**City:** Houston

**Contacts:**

***Contact 1:***

- **Name:** Saba Khan

- **Role:** CONTACT

***Contact 2:***

- **Name:** Ashrith Guha, MD

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 3:***

- **Name:** Arvind Bhimaraj, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** Houston Methodist DeBakey Heart and Vascular Center

**State:** Texas

**Status:** RECRUITING

**Zip:** 77030

#### Overall Officials

**Official 1:**

**Affiliation:** University of Kansas Medical Center

**Name:** Hirak Shah, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M9421

- Name: Heart Failure

- Relevance: HIGH

- As Found: Heart Failure

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006333

- Term: Heart Failure

### Misc Info Module

- Version Holder: 2024-05-31
