DCM Precision Medicine Study



Status:Recruiting
Conditions:Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:3/16/2019
Start Date:June 7, 2016
End Date:June 2021
Contact:Principal Investigator
Phone:614-688-1388

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Precision Medicine for Dilated Cardiomyopathy in European and African Ancestry

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.

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 DCM in groups defined by proband classification (familial/non-familial) and ancestry
(EA/AA); and (3) evaluate the impact of a randomized intervention to aid and direct family
communication on participation of at-risk family members in clinical screening and
appropriate follow-up surveillance for DCM. These aims will be accomplished by recruiting a
cohort of 1300 DCM probands (600 EA, 600 AA, 100 Hispanic ethnicity), performing
cardiovascular clinical screening of 2600 family members, performing genetic testing of
probands and affected family members by exome sequencing, returning genetic results, and
randomizing probands to an intervention to improve family communication regarding DCM risk.
Proving these hypotheses would be transformative for the field: rather than viewing DCM as
only a clinical diagnosis, cardiovascular professionals would understand DCM as a genetic
disease that should be managed using genetic diagnostic and family-based preventive
strategies. These study results would make precision medicine for DCM a reality.

Inclusion Criteria:

- 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).

Exclusion Criteria:

- 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).

- However, conventional risk factors for DCM, including obesity, routinely treated
hypertension, alcohol use, pregnancy or the peri-partum period, or left ventricular
noncompaction, will NOT be considered exclusion criteria.
We found this trial at
26
sites
1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Dallas, TX
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: Alanna Morris, MD
Phone: 404-712-0502
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Atlanta, GA
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Birmingham, AL
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Principal Investigator: Gordon Huggins, MD
Phone: 617-636-4884
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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Boston, MA
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Christopher Newton-Cheh, MD
Phone: 617-643-3615
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Boston, MA
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Wilson Tang, MD
Phone: 216-636-6153
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
Principal Investigator: Charles Moore, MD
Phone: 601-815-8702
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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Jackson, MS
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6200 Southwest 73rd StreetSouth
Miami, Florida 33143
Principal Investigator: Javier Jimenez, MD
Phone: 786-662-8467
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Miami, FL
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Seattle, Washington 98104
(206) 543-2100
Principal Investigator: Daniel Fishbein, MD
Phone: 206-685-4346
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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Seattle, WA
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Keith Aaronson, MD
Phone: 734-232-4606
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Ann Arbor, MI
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Baltimore, Maryland 20742
(301) 405-1000
Principal Investigator: Stephen Gottlieb, MD
Phone: 410-868-1575
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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Baltimore, MD
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Beverly Hills, California 90211
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Beverly Hills, CA
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Jane Wilcox, MD
Phone: 312-695-4965
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Chicago, IL
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: Ray Hershberger, MD
Phone: 614-688-9815
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Columbus, OH
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3300 Gallows Road
Fairfax, Virginia 22042
Principal Investigator: Palak Shah, MD
Phone: 703-776-3697
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Fairfax, VA
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6550 Fannin St
Houston, Texas 77030
(713) 790-3311
Principal Investigator: Barry H Trachtenberg, MD
Phone: 713-441-3910
Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
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Houston, TX
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757 Westwood Plaza
Los Angeles, California 90024
(310) 825-9111
UCLA Medical Center Founded in 1955, UCLA Medical Center became Ronald Reagan UCLA Medical Center...
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Los Angeles, CA
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New Orleans, Louisiana 70112
Principal Investigator: Frank Smart, MD
Phone: 504-568-2637
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New Orleans, LA
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New York, New York 10016
Principal Investigator: Stephen Pan, MD
Phone: 646-501-0119
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New York, NY
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Principal Investigator: Brian Lowes, MD
Phone: 402-559-8862
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Palo Alto, California 94304
Principal Investigator: Matthew Wheeler, MD
Phone: 415-430-7391
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Anjali Owens, MD
Phone: 215-615-3236
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Philadelphia, PA
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Saint Louis, Missouri 63110
Principal Investigator: Gregory Ewald, MD
Phone: 314-286-0541
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Saint Louis, MO
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Tucson, Arizona 85724
Principal Investigator: Nancy Sweitzer, MD
Phone: 520-626-7761
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Tucson, AZ
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110 Irving Street Northwest
Washington, District of Columbia 20010
Principal Investigator: Mark Hofmeyer, MD
Phone: 202-877-0613
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Washington,
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