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Hypertrophic Cardiomyopathy Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02806479
Recruitment Status : Completed
First Posted : June 20, 2016
Last Update Posted : September 16, 2020
Information provided by (Responsible Party):
Larisa Tereshchenko, Oregon Health and Science University

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

Condition or disease Intervention/treatment
Hypertrophic Cardiomyopathy Coronary Artery Disease Other: Observational: Arrhythmogenic Substrate

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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Pilot Observational Case-control Study of the Electrical Heterogeneity in Patients With Hypertrophic Cardiomyopathy and High Arrhythmic Risk
Actual Study Start Date : September 2016
Actual Primary Completion Date : September 2020
Actual Study Completion Date : September 2020

Group/Cohort Intervention/treatment
Case: Hypertrophic cardiomyopathy
HCM patients at high risk for ventricular arrhythmia
Other: Observational: Arrhythmogenic Substrate
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
Other: Observational: Arrhythmogenic Substrate
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

Primary Outcome Measures :
  1. Non-invasively reconstructed epicardial activation map [ Time Frame: within one day ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Case - Control study of hypertrophic cardiomyopathy patients at high risk for ventricular arrhythmias in comparison to three Controls groups

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02806479

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United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Publications of Results:
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Responsible Party: Larisa Tereshchenko, Assistant Professor, Oregon Health and Science University Identifier: NCT02806479    
Other Study ID Numbers: 15049
First Posted: June 20, 2016    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Cardiomyopathy, Hypertrophic
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Pathological Conditions, Anatomical
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Aortic Valve Disease
Heart Valve Diseases