Hypertrophic Cardiomyopathy Pilot Study
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ClinicalTrials.gov Identifier: NCT02806479 |
Recruitment Status :
Completed
First Posted : June 20, 2016
Last Update Posted : September 16, 2020
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Condition or disease | Intervention/treatment |
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Hypertrophic Cardiomyopathy Coronary Artery Disease | Other: Observational: Arrhythmogenic Substrate |
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 |
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Case: Hypertrophic cardiomyopathy
HCM patients at high risk for ventricular arrhythmia
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Other: Observational: Arrhythmogenic Substrate |
Control I: Healthy
Healthy Controls
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Control II: Post-MI with arrhythmogenic substrate
Ischemic cardiomyopathy patients with documented history of ventricular tachyarrhythmia and left ventricular hypertrophy
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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
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- Non-invasively reconstructed epicardial activation map [ Time Frame: within one day ]

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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 |
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

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 ClinicalTrials.gov identifier (NCT number): NCT02806479
United States, Oregon | |
Oregon Health and Science University | |
Portland, Oregon, United States, 97239 |
Responsible Party: | Larisa Tereshchenko, Assistant Professor, Oregon Health and Science University |
ClinicalTrials.gov 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 |
Coronary Artery Disease Cardiomyopathies Cardiomyopathy, Hypertrophic Hypertrophy Coronary Disease Myocardial Ischemia Heart Diseases Cardiovascular Diseases |
Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Pathological Conditions, Anatomical Aortic Stenosis, Subvalvular Aortic Valve Stenosis Heart Valve Diseases |