DCM Precision Medicine Study

NCT03037632 | Active Not Recruiting DMC

• 2 other identifiers: 2015H0309R01HL128857
• Study Type: interventional
• Target: 6,500
• Locations: 1 country
• Sites: 26

Brief 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.

Conditions

Idiopathic Dilated Cardiomyopathy

Outcome Measures

Primary Outcomes (2)

• Family clinical screening completed within 12 months from proband enrollment.

  The probability that a living first-degree relative (FDR) without a previous definitive DCM diagnosis completes clinical screening for DCM within 12 months after proband recruitment

  12 months from proband enrollment.

• Living first-degree relative adheres to cardiovascular surveillance recommendations after return of genetic results.

  The probability that a living first-degree relative adheres to surveillance recommendations within 15 months after the proband receives individual genetic test information.

  2.5 years

Study Arms (2)

Communication Tool

EXPERIMENTAL

Behavioral: Family Heart Talk Booklet

No Communication Tool

NO INTERVENTION

Interventions

Family Heart Talk Booklet BEHAVIORAL

Communication Tool

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

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 multi-system disease that may cause DCM (e.g., active connective tissue disease).
• 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).

Sponsors & Collaborators

• Ray Hershberger: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• National Human Genome Research Institute (NHGRI): collaborator

Study Sites (26)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

University of Arizona Sarver Heart Center

Tucson, Arizona, 85724, United States

Location

Cedars-Sinai Medical Center

Beverly Hills, California, 90211, United States

Location

UCLA Medical Center

Los Angeles, California, 90095, United States

Location

Stanford University

Palo Alto, California, 94304, United States

Location

Medstar Washington Hospital Center (DC)

Washington D.C., District of Columbia, 20010, United States

Location

South Miami Heart Center

Miami, Florida, 33143, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Louisiana State University Health Sciences Center in New Orleans

New Orleans, Louisiana, 70112, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

University of Michigan

Ann Arbor, Michigan, 48187, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

NYU School of Medicine

New York, New York, 10016, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Inova Heart and Vascular Institute

Fairfax, Virginia, 22042, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (21)

• Cowan JR, Hershberger RE. Transcriptomics and Beyond in Dilated Cardiomyopathy. JACC Basic Transl Sci. 2023 Apr 24;8(4):419-421. doi: 10.1016/j.jacbts.2023.01.016. eCollection 2023 Apr.

  PMID: 37138804 BACKGROUND

• Jordan E, Ni H, Parker P, Kinnamon DD, Owens A, Lowes B, Shenoy C, Martin CM, Judge DP, Fishbein DP, Stoller D, Minami E, Kransdorf E, Smart F, Haas GJ, Huggins GS, Ewald GA, Diamond J, Wilcox JE, Jimenez J, Wang J, Tallaj J, Drazner MH, Hofmeyer M, Wheeler MT, Pinzon OW, Shah P, Gottlieb SS, Katz S, Shore S, Tang WHW, Hershberger RE; DCM Precision Medicine study of the DCM Consortium. Implementing Precision Medicine for Dilated Cardiomyopathy: Insights from The DCM Consortium. medRxiv [Preprint]. 2024 Nov 26:2024.11.22.24317816. doi: 10.1101/2024.11.22.24317816.

  PMID: 39649582 BACKGROUND

• Kransdorf EP, Jain R, Mead JO, Haas G, Hofmeyer M, Ewald GA, Diamond J, Owens A, Lowes B, Stoller D, Tang WHW, Drazner MH, Martin CM, Shah P, Tallaj J, Katz S, Jimenez J, Shore S, Smart F, Wang J, Gottlieb SS, Judge DP, Huggins GS, Cowan J, Parker P, Cao J, Hurst NS, Jordan E, Ni H, Kinnamon DD, Hershberger RE. Evaluation of Women with Peripartum or Dilated Cardiomyopathy and Their First-Degree Relatives: The DCM Precision Medicine Study. medRxiv [Preprint]. 2025 Jun 8:2025.02.18.25322501. doi: 10.1101/2025.02.18.25322501.

  PMID: 40034776 BACKGROUND

• Hershberger RE, Ni H. Systemic Immune-Mediated Diseases and Dilated Cardiomyopathy. JACC Heart Fail. 2025 Jan;13(1):146-148. doi: 10.1016/j.jchf.2024.11.002. No abstract available.

  PMID: 39779179 BACKGROUND

• Ni H, Jordan E, Cao J, Kinnamon DD, Gottlieb SS, Hofmeyer M, Jimenez J, Judge DP, Kransdorf E, Morris AA, Owens A, Shah P, Tang WHW, Wang J, Hershberger RE. Knowledge of Genome Sequencing and Trust in Medical Researchers Among Patients of Different Racial and Ethnic Groups With Idiopathic Dilated Cardiomyopathy. JAMA Cardiol. 2023 Jan 1;8(1):33-42. doi: 10.1001/jamacardio.2022.4132.

  PMID: 36383367 BACKGROUND

• Jordan ES, Grover PL, Lin J, Starkey CA, Finley EA, Ni H, Hershberger RE. The DCM Project Portal: A direct-to-participant platform of The DCM Research Project. Am Heart J Plus. 2024 Feb;38:100356. doi: 10.1016/j.ahjo.2023.100356. Epub 2023 Dec 27.

  PMID: 38348286 BACKGROUND

• Hofmeyer M, Haas GJ, Jordan E, Cao J, Kransdorf E, Ewald GA, Morris AA, Owens A, Lowes B, Stoller D, Wilson Tang WH, Garg S, Trachtenberg BH, Shah P, Pamboukian SV, Sweitzer NK, Wheeler MT, Wilcox JE, Katz S, Pan S, Jimenez J, Smart F, Wang J, Gottlieb SS, Judge DP, Moore CK, Huggins GS, Kinnamon DD, Ni H, Hershberger RE; DCM Precision Medicine Study of the DCM Consortium. Rare Variant Genetics and Dilated Cardiomyopathy Severity: The DCM Precision Medicine Study. Circulation. 2023 Sep 12;148(11):872-881. doi: 10.1161/CIRCULATIONAHA.123.064847. Epub 2023 Aug 29.

  PMID: 37641966 BACKGROUND

• Kinnamon DD, Morales A, Bowen DJ, Burke W, Hershberger RE; DCM Consortium*. Toward Genetics-Driven Early Intervention in Dilated Cardiomyopathy: Design and Implementation of the DCM Precision Medicine Study. Circ Cardiovasc Genet. 2017 Dec;10(6):e001826. doi: 10.1161/CIRCGENETICS.117.001826.

  PMID: 29237686 BACKGROUND

• Morales A, Kinnamon DD, Jordan E, Platt J, Vatta M, Dorschner MO, Starkey CA, Mead JO, Ai T, Burke W, Gastier-Foster J, Jarvik GP, Rehm HL, Nickerson DA, Hershberger RE; DCM Precision Medicine study of the DCM Consortium; DCM Consortium institutions and personnel participating in this study: Study Principal Investigator and Co-Investigators,DCM Consortium Clinical Site Principal Investigators and Clinical Site Other Significant Contributors (OSC). The following clinical sites and individuals contributed to the submission of RO 1 H L 128857 as Site Principal Investigators (Site Pl) or as Other Significant Contributors (OSC),Dr. Huggins also served as study co-principal investigator,The following clinical site was added following approval of NHGRI supplemental funding but prior to initiation of enrollment,The following clinical sites were added following study activation. Variant Interpretation for Dilated Cardiomyopathy: Refinement of the American College of Medical Genetics and Genomics/ClinGen Guidelines for the DCM Precision Medicine Study. Circ Genom Precis Med. 2020 Apr;13(2):e002480. doi: 10.1161/CIRCGEN.119.002480. Epub 2020 Mar 11.

  PMID: 32160020 BACKGROUND

• Kinnamon DD, Jordan E, Haas GJ, Hofmeyer M, Kransdorf E, Ewald GA, Morris AA, Owens A, Lowes B, Stoller D, Tang WHW, Garg S, Trachtenberg BH, Shah P, Pamboukian SV, Sweitzer NK, Wheeler MT, Wilcox JE, Katz S, Pan S, Jimenez J, Aaronson KD, Fishbein DP, Smart F, Wang J, Gottlieb SS, Judge DP, Moore CK, Mead JO, Huggins GS, Ni H, Burke W, Hershberger RE; DCM Precision Medicine Study of the DCM Consortium. Effectiveness of the Family Heart Talk Communication Tool in Improving Family Member Screening for Dilated Cardiomyopathy: Results of a Randomized Trial. Circulation. 2023 Apr 25;147(17):1281-1290. doi: 10.1161/CIRCULATIONAHA.122.062507. Epub 2023 Mar 20.

  PMID: 36938756 BACKGROUND

• Haas GJ, Zareba KM, Ni H, Bello-Pardo E, Huggins GS, Hershberger RE; Study Principal Investigator (PI) and Co-Investigators: The Ohio State University. Validating an Idiopathic Dilated Cardiomyopathy Diagnosis Using Cardiovascular Magnetic Resonance: The Dilated Cardiomyopathy Precision Medicine Study. Circ Heart Fail. 2022 May;15(5):e008877. doi: 10.1161/CIRCHEARTFAILURE.121.008877. Epub 2022 Mar 4.

  PMID: 35240856 BACKGROUND

• Huggins GS, Kinnamon DD, Haas GJ, Jordan E, Hofmeyer M, Kransdorf E, Ewald GA, Morris AA, Owens A, Lowes B, Stoller D, Tang WHW, Garg S, Trachtenberg BH, Shah P, Pamboukian SV, Sweitzer NK, Wheeler MT, Wilcox JE, Katz S, Pan S, Jimenez J, Aaronson KD, Fishbein DP, Smart F, Wang J, Gottlieb SS, Judge DP, Moore CK, Mead JO, Ni H, Burke W, Hershberger RE; DCM Precision Medicine Study of the DCM Consortium. Prevalence and Cumulative Risk of Familial Idiopathic Dilated Cardiomyopathy. JAMA. 2022 Feb 1;327(5):454-463. doi: 10.1001/jama.2021.24674.

  PMID: 35103767 BACKGROUND

• Burke W, Hovick SR, Jordan E, Ni H, Kinnamon DD, Hershberger RE. Communal Coping as a Strategy to Enhance Family Engagement in Dilated Cardiomyopathy. Circ Genom Precis Med. 2022 Jun;15(3):e003541. doi: 10.1161/CIRCGEN.121.003541. Epub 2022 May 10.

  PMID: 35536229 BACKGROUND

• Trachtenberg BH, Jimenez J, Morris AA, Kransdorf E, Owens A, Fishbein DP, Jordan E, Kinnamon DD, Mead JO, Huggins GS, Hershberger RE; DCM Precision Medicine Study of the DCM Consortium. TTR variants in patients with dilated cardiomyopathy: An investigation of the DCM Precision Medicine Study. Genet Med. 2022 Jul;24(7):1495-1502. doi: 10.1016/j.gim.2022.03.011. Epub 2022 Apr 18.

  PMID: 35438637 BACKGROUND

• Hershberger RE, Cowan J, Jordan E, Kinnamon DD. The Complex and Diverse Genetic Architecture of Dilated Cardiomyopathy. Circ Res. 2021 May 14;128(10):1514-1532. doi: 10.1161/CIRCRESAHA.121.318157. Epub 2021 May 13.

  PMID: 33983834 BACKGROUND

• Hershberger RE. The Evolving Science of Dilated Cardiomyopathy. J Am Coll Cardiol. 2021 Oct 26;78(17):1700-1702. doi: 10.1016/j.jacc.2021.08.038. No abstract available.

  PMID: 34674814 BACKGROUND

• Ni H, Jordan E, Kinnamon DD, Cao J, Haas GJ, Hofmeyer M, Kransdorf E, Ewald GA, Morris AA, Owens A, Lowes B, Stoller D, Tang WHW, Garg S, Trachtenberg BH, Shah P, Pamboukian SV, Sweitzer NK, Wheeler MT, Wilcox JE, Katz S, Pan S, Jimenez J, Fishbein DP, Smart F, Wang J, Gottlieb SS, Judge DP, Moore CK, Huggins GS, Hershberger RE; DCM Precision Medicine Study of the DCM Consortium. Screening for Dilated Cardiomyopathy in At-Risk First-Degree Relatives. J Am Coll Cardiol. 2023 May 30;81(21):2059-2071. doi: 10.1016/j.jacc.2023.03.419.

  PMID: 37225358 BACKGROUND

• Jordan E, Kinnamon DD, Haas GJ, Hofmeyer M, Kransdorf E, Ewald GA, Morris AA, Owens A, Lowes B, Stoller D, Tang WHW, Garg S, Trachtenberg BH, Shah P, Pamboukian SV, Sweitzer NK, Wheeler MT, Wilcox JE, Katz S, Pan S, Jimenez J, Fishbein DP, Smart F, Wang J, Gottlieb SS, Judge DP, Moore CK, Mead JO, Hurst N, Cao J, Huggins GS, Cowan J, Ni H, Rehm HL, Jarvik GP, Vatta M, Burke W, Hershberger RE; DCM Precision Medicine Study of the DCM Consortium. Genetic Architecture of Dilated Cardiomyopathy in Individuals of African and European Ancestry. JAMA. 2023 Aug 1;330(5):432-441. doi: 10.1001/jama.2023.11970.

  PMID: 37526719 BACKGROUND

• Ni H, Cao J, Kinnamon DD, Jordan E, Haas GJ, Hofmeyer M, Kransdorf EP, Diamond J, Owens A, Lowes B, Stoller D, Tang WHW, Drazner MH, Shah P, Wilcox JE, Katz SD, Jimenez J, Shore S, Judge DP, Mead JO, Cowan J, Parker PK, Huggins GS, Hershberger RE. Antecedent Flu-Like Illness and Onset of Idiopathic Dilated Cardiomyopathy: The DCM Precision Medicine Study. Circ Heart Fail. 2025 May;18(5):e012602. doi: 10.1161/CIRCHEARTFAILURE.124.012602. Epub 2025 Apr 14.

  PMID: 40392911 DERIVED

• Jimenez J, Ni H, Katz SD, Haas GJ, Cao J, Rubens M, Chaparro S, Saxena A, Hofmeyer M, Kransdorf E, Ewald GA, Morris AA, Owens A, Lowes B, Stoller D, Tang WHW, Shah P, Wilcox JE, Smart F, Wang J, Gottlieb SS, Judge DP, Mead JO, Hurst N, Parker PK, Huggins GS, Jordan E, Kinnamon DD, Hershberger RE; DCM Precision Medicine Study of the DCM Consortium. Alcohol Exposure Among Patients With Dilated Cardiomyopathy and Their First-Degree Relatives: The DCM Precision Medicine Study. Circ Genom Precis Med. 2025 Apr;18(2):e004946. doi: 10.1161/CIRCGEN.124.004946. Epub 2025 Mar 28.

  PMID: 40151927 DERIVED

• Wilcox JE, Beussink-Nelson L, Cao J, Kumar R, Jordan E, Ni H, Shah SJ, Hershberger RE, Kinnamon DD. Differences in Cardiac Mechanics among Genetically At-Risk First-Degree Relatives: The DCM Precision Medicine Study. medRxiv [Preprint]. 2023 Jun 4:2023.05.30.23290123. doi: 10.1101/2023.05.30.23290123.

  PMID: 37398079 DERIVED

Related Links

• Additional information regarding DCM Precision Medicine Study information provided on website.

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Blinded until intervention is assigned to subject.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 27, 2017
• First Posted: January 31, 2017
• Study Start: June 7, 2016
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (26)