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
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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.