Hypertrophic Cardiomyopathy Pilot Study

NCT ID: NCT02806479

Last Updated: 2020-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-30

Study Completion Date

2020-09-30

Brief Summary

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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

Detailed Description

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Conditions

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Hypertrophic Cardiomyopathy Coronary Artery Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Case: Hypertrophic cardiomyopathy

HCM patients at high risk for ventricular arrhythmia

Observational: Arrhythmogenic Substrate

Intervention Type OTHER

Control I: Healthy

Healthy Controls

No interventions assigned to this group

Control II: Post-MI with arrhythmogenic substrate

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

Observational: Arrhythmogenic Substrate

Intervention Type OTHER

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

No interventions assigned to this group

Interventions

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Observational: Arrhythmogenic Substrate

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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Larisa Tereshchenko

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Oregon Health and Science University

Portland, Oregon, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 32390862 (View on PubMed)

Other Identifiers

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15049

Identifier Type: -

Identifier Source: org_study_id

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