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8110 Gatehouse Road, Falls Church, VA 22042

DCM Precision Medicine Study

General Information

Age Group

Adult

Status

Active

Protocol Number

NCT03037632

Background Information

The purpose of this study is to identify gene changes that cause DCM and gene differences that influence the development and severity of DCM. These genetic studies may identify a change in a gene that has already been linked with DCM, a change in a gene not previously associated with DCM, or these studies may identify a gene or genes that affect the development and severity of the DCM. With this knowledge we hope to have a better understanding of how genes and gene changes cause DCM.

Offered At

Inova Fairfax Hospital

3300 Gallows Road

Falls Church, VA 22042

Principal Investigator

Palak Shah, MD

Eligibility Information

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).

Ineligibility Information

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.