Dilated Cardiomyopathy-Cardiac Magnetic Resonance (DCM-CMR) Ancillary Study (NCT04638621) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Dilated Cardiomyopathy-Cardiac Magnetic Resonance (DCM-CMR) Ancillary Study
United States650 participantsStarted 2021-04-01
Plain-language summary
The Dilated Cardiomyopathy-Cardiac Magnetic Resonance (DCM-CMR) Study is an ancillary study from the parent study, DCM Precision Medicine Study. The rationale for the DCM-CMR study is to leverage cardiac magnetic resonance (CMR) imaging to detect earliest findings of DCM in the at-risk family members enrolled into the parent study.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. The FDR's proband was enrolled in the DCM Precision Medicine Study at 1 of 9 participating sites, or exceptions granted by study PI.
✓. The FDR's proband has had one or more variants identified, including P, LP and VUS.
✓. The FDR is able report to one of the participating sites for study enrollment.
✓. The FDR has no current contraindication for CMR (glomerular filtration rate (GFR) \<30 mL/min/1.73 m2, non-compatible device implant, or allergy to gadolinium contrast).
✓. The FDR has had no prior heart transplant.
✓. The FDR is ≥18 years of age.
✓. All races/ethnicity
✓. Ability to give informed consent.
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.
What they're measuring
1
The association between CMR-derived tissue characteristics and the number (burden) of the proband's variants in DCM genes in at-risk first-degree relatives
Timeframe: The initial 2.5 years of the study.
2
The changes in CMR tissue characterization over time in family members scanned for Outcome 1 who had normal left ventricular size and function
. Other detectable causes of dilated cardiomyopathy, including sarcoid and hemochromatosis.
✕. Other active multisystem disease, even if very rare, that may plausibly cause DCM (e.g., hypereosinophilic syndrome, cardiac involvement with connective tissue disease, Loeffler's endocarditis, endomyocardial fibrosis, etc) are excluded. Please call the PI to discuss if uncertain or not clear.
✕. 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). This includes profound hypertension associated with other multisystem disease (e.g., scleroderma, other vasculitides, etc).