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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.
 
ClinicalTrials.gov Identifier: NCT02806479
Recruitment Status : Active, not recruiting
First Posted : June 20, 2016
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Larisa Tereshchenko, Oregon Health and Science University

Study Description
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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

Study Design
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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
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy

Groups and Cohorts
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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


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

Eligibility Criteria
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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
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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT02806479


Locations
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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
More Information
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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: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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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