Using cardiac MRI to detect early signs of dilated cardiomyopathy in at-risk family members

Precision Medicine for Dilated Cardiomyopathy-Cardiac Magnetic Resonance to Identify Early Family Phenotypes

This study is testing if a special heart scan can find early signs of dilated cardiomyopathy in family members of people who have the condition.

Quick facts

• Study type: Observational
• Enrollment: 650 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ohio State University (Academic / other)
• Locations: 1 site (Columbus, Ohio)
• Trial ID: NCT04638621 on ClinicalTrials.gov

What this trial studies

The DCM-CMR study aims to utilize cardiac magnetic resonance imaging to identify early signs of dilated cardiomyopathy (DCM) in first-degree relatives of individuals diagnosed with the condition. This observational study is part of a larger DCM Precision Medicine Study and focuses on family members who may carry genetic variants associated with DCM. By detecting myocardial tissue changes before structural and functional heart issues arise, the study seeks to improve early intervention strategies. Participants will undergo CMR imaging to assess their myocardial tissue characteristics and correlate these findings with genetic risk factors.

Who should consider this trial

Good fit: Ideal candidates include first-degree relatives of individuals with dilated cardiomyopathy who have been identified as carrying pathogenic or likely pathogenic genetic variants.

Not a fit: Patients with coronary artery disease or those who have had a heart transplant may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to earlier diagnosis and intervention for individuals at genetic risk of developing dilated cardiomyopathy.

How similar studies have performed: Other studies have shown promise in using cardiac MRI for early detection of heart conditions, suggesting that this approach may be effective.

Eligibility criteria

Inclusion Criteria:

1. The FDR's proband was enrolled in the DCM Precision Medicine Study at 1 of 9 participating sites, or exceptions granted by study PI.
2. The FDR's proband has had one or more variants identified, including P, LP and VUS.
3. The FDR is able report to one of the participating sites for study enrollment.
4. 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).
5. The FDR has had no prior heart transplant.
6. The FDR is ≥18 years of age.
7. All races/ethnicity
8. Ability to give informed consent.
9. Ability to communicate in English.
10. Subject is not pregnant (CMR may be conducted 3-6 months post delivery)
11. Willingness to participate in a family-based study (subject willing to interact with OSU).

Exclusion Criteria:

1. Coronary artery disease (CAD) causing ischemic cardiomyopathy (\> 50% narrowing, any major epicardial coronary artery).
2. Primary valvular disease.
3. Adriamycin or other cardiotoxic drug exposure.
4. Other forms of cardiomyopathy: Hypertrophic, Restrictive, or Arrhythmogenic Right Ventricular Dysplasia/Cardiomyopathy.
5. Congenital heart disease.
6. Other detectable causes of dilated cardiomyopathy, including sarcoid and hemochromatosis.
7. 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.
8. 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).

Where this trial is running

Columbus, Ohio

• The Ohio State University — Columbus, Ohio, United States (Recruiting)

Study contacts

• Principal investigator: Ray Hershberger, MD — Ohio State University
• Study coordinator: Principal Investigator

Conditions Dilated Cardiomyopathy