Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:26 PM
Ignite Modification Date:
2025-12-24 @ 9:26 PM
NCT ID:
NCT03037632
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT03037632
Study Brief:
Protocol Section:
NCT03037632