Family Communication Intervention for Dilated Cardiomyopathy

Not currently recruiting at 28 trial locations

Overseen By Principal Investigator

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Ray Hershberger

Must not be taking: Cardiotoxic drugs

Disqualifiers: Coronary artery disease, Valvular disease, Congenital heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the genetic basis of dilated cardiomyopathy (DCM), a condition where the heart struggles to pump blood effectively. Researchers aim to determine if a communication tool, such as the Family Heart Talk Booklet, can facilitate family discussions about the condition and encourage more family members to undergo screening. Participants with DCM, without other known causes like coronary artery disease, might be suitable candidates. The trial seeks to determine if this approach can improve early detection and management within families. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could enhance family communication and early detection strategies for DCM.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this family communication intervention is safe?

Research shows that the Family Heart Talk Booklet is a safe and helpful tool designed to assist families in discussing genetic risks related to dilated cardiomyopathy (DCM), a heart condition. Studies have found that this booklet enhances family communication without any reported side effects or safety issues. As a simple guide, it helps individuals share important health information with their family members. Since it is merely a booklet and does not involve medical treatments or drugs, it carries no risks like those associated with other treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Family Heart Talk Booklet because it focuses on improving family communication for managing dilated cardiomyopathy, a departure from the typical medical treatments like medications, lifestyle changes, or surgical options. Unlike standard treatments that primarily target the patient's physical symptoms, this approach aims to enhance understanding and support among family members, potentially leading to better health outcomes. By fostering open discussions, the booklet might help families make more informed decisions and provide stronger emotional support, which could be a game-changer for managing this heart condition.

What evidence suggests that this communication tool is effective for improving family member clinical screening in dilated cardiomyopathy?

Research has shown that the Family Heart Talk booklet, which participants in this trial may receive, helps families discuss the genetic risks of Dilated Cardiomyopathy (DCM). Studies have found that this booklet increases the likelihood of family members getting checked for DCM, which is crucial for early detection and treatment. The booklet is easy to use and quick for doctors to introduce to patients. It is an affordable tool that has been proven to increase the number of family members getting screened, aiding in the earlier identification and management of DCM in families. ^{1 2 3 5 6}

Who Is on the Research Team?

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

Non-Hispanic and Hispanic ethnicity

All races (PI pre-approval required for recruitment beyond pre-specified recruitment targets)

Ability to give informed consent

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.

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?

Group I: Communication Tool Experimental Treatment 1 Intervention

Group II: No Communication Tool Active Control 1 Intervention

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+

Citations

1. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.122.062507

Effectiveness of the Family Heart Talk Communication Tool ... The DCM Precision Medicine Study developed Family Heart Talk, a booklet designed to help probands with DCM communicate genetic risk and the need ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36938756/

Effectiveness of the Family Heart Talk Communication Tool in ... Family Heart Talk, a booklet that can be provided to patients with DCM by clinicians with minimal additional time investment, was effective in increasing ...

3. wexnermedical.osu.edu wexnermedical.osu.edu/mediaroom/pressreleaselisting/dcm-booklet

Informational booklet improved family screening for ... The 'Family Heart Talk' booklet is an effective tool that is low cost and requires a minimal time investment to implement into clinical care ...

4. profiles.wustl.edu profiles.wustl.edu/en/publications/effectiveness-of-the-family-heart-talk-communication-tool-in-impr

Effectiveness of the Family Heart Talk Communication Tool ... The effectiveness of the Family Heart Talk booklet in increasing cardiovascular clinical screening uptake among first-degree relatives was ...

5. researchgate.net researchgate.net/publication/369377253_Effectiveness_of_the_Family_Heart_Talk_Communication_Tool_in_Improving_Family_Member_Screening_for_Dilated_Cardiomyopathy_Results_of_a_Randomized_Trial

Effectiveness of the Family Heart Talk Communication Tool ... Effectiveness of the Family Heart Talk Communication Tool in Improving Family Member Screening for Dilated Cardiomyopathy: Results of a Randomized Trial.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03037632

NCT03037632 | DCM Precision Medicine Study 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 ...