A Study About the Natural History in Adults With BAG3 Dilated Cardiomyopathy (a Type of Heart Disease) (BAG3 DCM)
Cardiomyopathy, Dilated, Bcl-2 Anathogene-3 (BAG3) Dilated Cardiomyopathy (DCM)
About this trial
This is an observational trial for Cardiomyopathy, Dilated focused on measuring BAG3, DCM, cardiomyopathy, dilated cardiomyopathy, heritable heart disease, heart disease
Eligibility Criteria
Key Inclusion Criteria: Documented BAG3 mutation that causes or is likely to cause dilated cardiomyopathy New York Heart Association (NYHA) Class I-IV at screening (Stage B-D) Left Ventricular Ejection Fraction ≤50% (i.e., Reduced Heart Function) Key Exclusion Criteria: Acute decompensated heart failure within 1 month prior to enrollment.(such as hospitalization) Any of the following within 3 months prior to screening: myocardial infarction (MI), cardiac surgical procedures (other than for pacemaker/ICD/CRT-defibrillator [CRT-D] implantation), acute coronary syndrome, or hospitalization for cardiac arrhythmia. History of heart transplantation eGFR <30 mL/min/1.73 m2 (significantly impaired kidney function) Noncardiac condition that limits lifespan to <1 year. Presence of other form(s) of cardiomyopathy contributing to heart failure Previous administration with an investigational drug within 30 days (or as determined by the local requirement). No more than 3 first-degree members of the same family who are already participating in the study
Sites / Locations
- University of Colorado Anschutz Medical Campus, Fitzsimons Building
- University of Colorado Clinical and Translational Research Center
- University of Colorado Denver, Anschutz Medical Campus
- University of Colorado Hospital
- Brigham & Women's HospitalRecruiting
- Brigham and Women's HospitalRecruiting
- Montefiore Medical Center(Hutchinson Metro Center)Recruiting
- Montefiore Medical Center(Medical Arts Pavilion)Recruiting
- Montefiore Medical CenterRecruiting
- Division of Heart Failure and Transplantation(Hospital of the University of Pennsylvania)
- Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego - Panstwowy Instytut BadawczyRecruiting
- Hospital Universitario Puerta de Hierro MajadahondaRecruiting
- Hospital Clinico Universitario Virgen de La ArrixacaRecruiting
- CHUAC-Complejo Hospitalario Universitario A CoruñaRecruiting
- Hospital Universitario 12 de Octubre
- The Royal Brompton and Harefield HospitalsRecruiting
Arms of the Study
Arm 1
BAG3 DCM
A single arm observational trial where all participants will undergo the same schedule of assessments.