DCM Precision Medicine Study (NCT03037632) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
DCM Precision Medicine Study
United States6,500 participantsStarted 2016-06-07
Plain-language summary
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.
Who can participate
SexALL
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Inclusion Criteria:
* 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:
* 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)…
What they're measuring
1
Family clinical screening completed within 12 months from proband enrollment.
Timeframe: 12 months from proband enrollment.
2
Living first-degree relative adheres to cardiovascular surveillance recommendations after return of genetic results.