Dilated Cardiomyopathy-Cardiac Magnetic Resonance (DCM-CMR) Ancillary Study

NCT04638621 | Active Not Recruiting

• 2 other identifiers: 831408R01HL148581-01A1
• Study Type: observational
• Target: 650
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dilated Cardiomyopathy

Outcome Measures

Primary Outcomes (2)

• 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

  The burden of likely pathogenic or pathogenic variants in DCM genes in first-degree relatives and the association with worse values of CMR measures of myocardial tissue characterization will be analyzed, after controlling for biologically relevant covariates.

  The initial 2.5 years of the study.

• The changes in CMR tissue characterization over time in family members scanned for Outcome 1 who had normal left ventricular size and function

  The measures of myocardial tissue characterization in first-degree relatives will be evaluated in a follow up CMR exam, on average, at 2.5 years following a first DCM exam, to assess changes in myocardial structure and function, again analyzed in association with the burden of likely pathogenic or pathogenic variants in DCM genes.

  A subsequent 2.5 year time period

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

650 FDRs of probands from the parent study (DCM Precision Medicine Study) with no contraindication to CMR with contrast.

You may qualify if:

• 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.
• Ability to communicate in English.
• Subject is not pregnant (CMR may be conducted 3-6 months post delivery)
• Willingness to participate in a family-based study (subject willing to interact with OSU).

You may not qualify if:

• 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 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).

Sponsors & Collaborators

• Ohio State University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

DNA, serum and plasma are collected.

MeSH Terms

Conditions

Cardiomyopathy, Dilated

Condition Hierarchy (Ancestors)

Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Cardiomyopathies; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Ray Hershberger, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

• Karolina Zareba, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

• Daniel Kinnamon, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Human Genetics, and Cardiovascular Medicine

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: November 20, 2020
• Study Start: April 1, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

US (1)