6500 Participants Needed

Family Communication Intervention for Dilated Cardiomyopathy

Recruiting at 26 trial locations
CR
PI
Overseen ByPrincipal Investigator
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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 Is on the Research Team?

RH

Ray Hershberger, MD

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

This study is for individuals of any age with dilated cardiomyopathy (DCM), a heart condition where the heart's ability to pump blood is decreased. Participants must not have other detectable causes for DCM, severe untreated hypertension, or active diseases that could cause DCM. They should be able to give consent and communicate in English or Spanish at certain sites.

Inclusion Criteria

Ability to communicate in English (except Spanish language at sites approved to recruit individuals of Hispanic ethnicity)
My heart condition is not caused by anything other than genetics.
Non-Hispanic and Hispanic ethnicity
See 5 more

Exclusion Criteria

I have heart disease due to narrowed arteries.
I have a heart valve condition.
I have been treated with Adriamycin or similar heart-affecting drugs.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Recruitment and Baseline Assessment

Recruitment of 1300 DCM probands and baseline cardiovascular clinical screening of 2600 family members

12 months

Genetic Testing and Intervention

Genetic testing of probands and affected family members by exome sequencing, return of genetic results, and randomization to intervention for family communication

6 months

Follow-up

Participants are monitored for adherence to cardiovascular surveillance recommendations after return of genetic results

2.5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Family Heart Talk Booklet
Trial Overview The trial aims to understand if genetics play a major role in DCM and assesses the effectiveness of using a 'Family Heart Talk Booklet' to improve clinical screening among family members.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Communication ToolExperimental Treatment1 Intervention
Group II: No Communication ToolActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ray Hershberger

Lead Sponsor

Trials
1
Recruited
6,500+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

National Human Genome Research Institute (NHGRI)

Collaborator

Trials
273
Recruited
299,000+
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