Clinical Trial: DCM Precision Medicine Study
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Precision Medicine for Dilated Cardiomyopathy in European and African Ancestry
Brief Summary: The study aim of the DCM Precision Medicine Study is to test the hypothesis that DCM has a substantial genetic basis and to evaluate the effectiveness of a family communication intervention in improving the uptake and impact of family member clinical screening.
Detailed Summary: Dilated cardiomyopathy of unknown cause (DCM), known clinically as idiopathic dilated cardiomypathy, is the most common cardiomyopathy and is the leading cause of heart transplantation. DCM affects approximately one million individuals, and so has a major impact on US public health. DCM is commonly asymptomatic until very late in its course when it causes heart failure, disability, and death. Because of its clinical course, any means to identify patients at risk for DCM or to detect DCM in its asymptomatic phase could provide enormous opportunity for intervention to extend lives and prevent late-stage disease. Within this paradigm precision medicine for DCM could greatly impact health care outcomes and costs. Recent advances in DCM genetics have introduced these possibilities, but unresolved questions of familial recurrence risk, genetic etiology, racial differences, and family-based screening must be addressed to move ahead. The central hypothesis of this study, based on published studies of the investigative group, states that DCM has substantial genetic basis. For this study the investigators hypothesize that: (a) 35% of probands of both European and African ancestry (EA/AA) will be classified as familial in a cohort recruited in a multicenter US consortium and given explicit recommendations and assistance to achieve the clinical screening of relatives; (b) approximately 40% of DCM probands, whether categorized as familial or non-familial, or as EA or AA, will have pathogenic or likely pathogenic variants in genes previously implicated in DCM; and (c) a tailored intervention to help DCM probands communicate DCM risk to their family members will improve the uptake and impact of necessary clinical and genetic testing. To test these hypotheses, the investigators propose to: (1) estimate and compare the frequencies of EA and AA DCM probands classified as having familial DCM; (2) estimate and compare the proportions of probands with an identifiable genetic cause of DC
Sponsor: Ray Hershberger
Current Primary Outcome:
- Family clinical screening completed within 12 months from proband enrollment. [ Time Frame: 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
- Living first-degree relative adheres to cardiovascular surveillance recommendations after return of genetic results. [ Time Frame: 2.5 years ]The probability that a living first-degree relative adheres to surveillance recommendations within 15 months after the proband receives individual genetic test information.
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Ohio State University
Dates:
Date Received: January 27, 2017
Date Started: June 7, 2016
Date Completion: June 2021
Last Updated: January 30, 2017
Last Verified: January 2017
