DCM Precision Medicine Study

Trial ID or NCT#

NCT03037632

Status

not recruiting iconNOT RECRUITING

Purpose

The aims of the DCM Precision Medicine Study are to test the hypothesis that DCM has substantial genetic basis and to evaluate the effectiveness of a family communication intervention in improving the uptake and impact of family member clinical screening.

Official Title

Precision Medicine for Dilated Cardiomyopathy in European and African Ancestry

Eligibility Criteria

Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - Meeting criteria for dilated cardiomyopathy (DCM) : - Left ventricular ejection fraction <50% - Left ventricular enlargement (A left ventricular end-diastolic dimension > 95%tile population standard based on gender and height). - Detectable causes of cardiomyopathy, except genetic, excluded beyond a reasonable doubt at the time of DCM diagnosis (that is, meeting clinical criteria for idiopathic DCM) - Any age (including children) - Non-Hispanic and Hispanic ethnicity - All races (PI pre-approval required for recruitment beyond pre-specified recruitment targets). - Ability to give informed consent - Ability to communicate in English (except Spanish language at sites approved to recruit individuals of Hispanic ethnicity) - Willingness to participate in a family-based study (patient willing to work with a clinical site and/or OSU to facilitate the recruitment and enrollment of family members to the study).
Exclusion Criteria:
  1. - Coronary artery disease (CAD) causing ischemic cardiomyopathy (> 50% narrowing, any major epicardial coronary artery) - Primary valvular disease - Adriamycin or other cardiotoxic drug exposure - Other forms of cardiomyopathy: Hypertrophic, Restrictive, or Arrhythmogenic Right Ventricular Dysplasia/Cardiomyopathy - Congenital heart disease - Other detectable causes of dilated cardiomyopathy, including sarcoid and hemochromatosis. - Other active multi-system disease that may cause DCM (e.g., active connective tissue disease). - Severe and untreated or untreatable hypertension (systolic blood pressures routinely greater than 180 mm Hg and/or diastolic blood pressures greater than 120 mm Hg, and if resistant to multidrug treatment). - However, conventional risk factors for DCM, including obesity, routinely treated hypertension, alcohol use, pregnancy or the peri-partum period, or left ventricular noncompaction, will NOT be considered exclusion criteria.
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Investigator(s)

Euan A. Ashley
Euan A. Ashley
Cardiologist, Heart failure cardiologist
Associate Dean, School of Medicine, Roger and Joelle Burnell Professor of Genomics and Precision Health, Professor of Medicine (Cardiovascular Medicine), of Genetics, of Biomedical Data Science and, by courtesy, of Pathology

Contact us to find out if this trial is right for you.

Contact

DCM Coordinators
650 725-6911

View on ClinicalTrials.gov