## Protocol Section
### Identification Module
**NCT ID:** NCT02806479

**Brief Title:** Hypertrophic Cardiomyopathy Pilot Study

**Official Title:** Pilot Observational Case-control Study of the Electrical Heterogeneity in Patients With Hypertrophic Cardiomyopathy and High Arrhythmic Risk

#### Organization Study ID Info
**ID:** 15049
#### Organization
**Class:** OTHER
**Full Name:** Oregon Health and Science University
### Status Module
#### Completion Date
**Date:** 2020-09

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-09-16

**Type:** ACTUAL

**Last Update Submit Date:** 2020-09-14

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2020-09

**Type:** ACTUAL

#### Start Date
**Date:** 2016-09

**Type:** ACTUAL

**Status Verified Date:** 2020-09

#### Study First Post Date
**Date:** 2016-06-20
**Type:** ESTIMATED
**Study First Submit Date:** 2016-06-16
**Study First Submit QC Date:** 2016-06-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Oregon Health and Science University

#### Responsible Party

**Investigator Affiliation:** Oregon Health and Science University

**Investigator Full Name:** Larisa Tereshchenko

**Investigator Title:** Assistant Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This study evaluates mechanisms of arrhythmogenicity in hypertrophic cardiomyopathy, in comparison to patients with well-understood arrhythmogenic substrate (ischemic cardiomyopathy), as well as to individuals free from arrhythmogenic substrate

### Conditions Module

**Conditions:**

- Hypertrophic Cardiomyopathy

- Coronary Artery Disease

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 40

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** HCM patients at high risk for ventricular arrhythmia

**Intervention Names:**

- Other: Observational: Arrhythmogenic Substrate

**Label:** Case: Hypertrophic cardiomyopathy

#### Arm Group 2

**Description:** Healthy Controls

**Label:** Control I: Healthy

#### Arm Group 3

**Description:** Ischemic cardiomyopathy patients with documented history of ventricular tachyarrhythmia and left ventricular hypertrophy

**Intervention Names:**

- Other: Observational: Arrhythmogenic Substrate

**Label:** Control II: Post-MI with arrhythmogenic substrate

#### Arm Group 4

**Description:** Ischemic cardiomyopathy patients without ventricular arrhythmia, as proven by non-inducibility and history of freedom from ventricular tachyarrhythmia during at least one ICD generator life

**Label:** Control III: VT/VF-free ischemic cardiomyopathy

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Case: Hypertrophic cardiomyopathy

- Control II: Post-MI with arrhythmogenic substrate

**Name:** Observational: Arrhythmogenic Substrate

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Measure:** Non-invasively reconstructed epicardial activation map

**Time Frame:** within one day

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Diagnosed HCM
* Documented history of sustained ventricular tachyarrhythmia or resuscitated sudden cardiac arrest
* Maximal left ventricular wall thickness of \> 30mm
* Extensive fibrosis on cardiac MRI (\>15% of total myocardial volume)
* \>7.5%/5-year risk of sudden cardiac death as determined by HCM risk-SCD

Exclusion Criteria:

* age \< 18 years
* Pregnancy
* Atrial Fibrillation

**Maximum Age:** 99 Years

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Case - Control study of hypertrophic cardiomyopathy patients at high risk for ventricular arrhythmias in comparison to three Controls groups

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Portland

**Country:** United States

**Facility:** Oregon Health and Science University

**State:** Oregon

**Zip:** 97239

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Perez-Alday EA, Haq KT, German DM, Hamilton C, Johnson K, Phan F, Rogovoy NM, Yang K, Wirth A, Thomas JA, Dalouk K, Fuss C, Ferencik M, Heitner S, Tereshchenko LG. Mechanisms of Arrhythmogenicity in Hypertrophic Cardiomyopathy: Insight From Non-invasive Electrocardiographic Imaging. Front Physiol. 2020 Apr 24;11:344. doi: 10.3389/fphys.2020.00344. eCollection 2020.

**PMID:** 32390862

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000003327

- Term: Coronary Disease

- ID: D000017202

- Term: Myocardial Ischemia

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000001161

- Term: Arteriosclerosis

- ID: D000001157

- Term: Arterial Occlusive Diseases

- ID: D000014652

- Term: Vascular Diseases

- ID: D000020763

- Term: Pathological Conditions, Anatomical

- ID: D000001020

- Term: Aortic Stenosis, Subvalvular

- ID: D000001024

- Term: Aortic Valve Stenosis

- ID: D000082862

- Term: Aortic Valve Disease

- ID: D000006349

- Term: Heart Valve Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M12154

- Name: Cardiomyopathies

- Relevance: HIGH

- As Found: Cardiomyopathy

- ID: M6549

- Name: Coronary Disease

- Relevance: LOW

- As Found: Unknown

- ID: M6546

- Name: Coronary Artery Disease

- Relevance: HIGH

- As Found: Coronary Artery Disease

- ID: M19506

- Name: Myocardial Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M10035

- Name: Hypertrophy

- Relevance: HIGH

- As Found: Hypertrophic

- ID: M5568

- Name: Cardiomyopathy, Hypertrophic

- Relevance: HIGH

- As Found: Hypertrophic Cardiomyopathy

- ID: M10543

- Name: Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4469

- Name: Arteriosclerosis

- Relevance: LOW

- As Found: Unknown

- ID: M4465

- Name: Arterial Occlusive Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M22519

- Name: Pathological Conditions, Anatomical

- Relevance: LOW

- As Found: Unknown

- ID: M6475

- Name: Constriction, Pathologic

- Relevance: LOW

- As Found: Unknown

- ID: M4340

- Name: Aortic Valve Stenosis

- Relevance: LOW

- As Found: Unknown

- ID: M2379

- Name: Aortic Valve Disease

- Relevance: LOW

- As Found: Unknown

- ID: M9437

- Name: Heart Valve Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T449

- Name: Aortic Valve Stenosis

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003324

- Term: Coronary Artery Disease

- ID: D000009202

- Term: Cardiomyopathies

- ID: D000002312

- Term: Cardiomyopathy, Hypertrophic

- ID: D000006984

- Term: Hypertrophy

### Misc Info Module

- Version Holder: 2024-05-24
