Hypertrophic Cardiomyopathy Pilot Study
Pilot Observational Case-control Study of the Electrical Heterogeneity in Patients With Hypertrophic Cardiomyopathy and High Arrhythmic Risk
1 other identifier
observational
40
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2016
CompletedFirst Posted
Study publicly available on registry
June 20, 2016
CompletedStudy Start
First participant enrolled
September 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedSeptember 16, 2020
September 1, 2020
4 years
June 16, 2016
September 14, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Non-invasively reconstructed epicardial activation map
within one day
Study Arms (4)
Case: Hypertrophic cardiomyopathy
HCM patients at high risk for ventricular arrhythmia
Control I: Healthy
Healthy Controls
Control II: Post-MI with arrhythmogenic substrate
Ischemic cardiomyopathy patients with documented history of ventricular tachyarrhythmia and left ventricular hypertrophy
Control III: VT/VF-free ischemic cardiomyopathy
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
Interventions
Eligibility Criteria
Case - Control study of hypertrophic cardiomyopathy patients at high risk for ventricular arrhythmias in comparison to three Controls groups
You may qualify if:
- 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
You may not qualify if:
- age \< 18 years
- Pregnancy
- Atrial Fibrillation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oregon Health and Science University
Portland, Oregon, 97239, United States
Related Publications (1)
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: 32390862RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
June 16, 2016
First Posted
June 20, 2016
Study Start
September 1, 2016
Primary Completion
September 1, 2020
Study Completion
September 1, 2020
Last Updated
September 16, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share