Status:
ACTIVE_NOT_RECRUITING
A Study About the Natural History in Adults With BAG3 Dilated Cardiomyopathy (a Type of Heart Disease) (BAG3 DCM)
Lead Sponsor:
Alexion Pharmaceuticals, Inc.
Conditions:
Cardiomyopathy, Dilated
Bcl-2 Anathogene-3 (BAG3) Dilated Cardiomyopathy (DCM)
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to learn about the natural progression of DCM (dilated cardiomyopathy) caused by BAG3 gene mutations. DCM is a condition as the heart muscle is weakened and the heart beco...
Eligibility Criteria
Inclusion
- Documented BAG3 mutation that causes or is likely to cause dilated cardiomyopathy
- Heart failure Stage B-D, New York Heart Association (NYHA) Class I-IV
- Left Ventricular Ejection Fraction ≤50% (i.e., Reduced Heart Function)
Exclusion
- 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
Key Trial Info
Start Date :
October 14 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 12 2027
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT05981092
Start Date
October 14 2022
End Date
August 12 2027
Last Update
December 11 2025
Active Locations (15)
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1
Research Site
Palo Alto, California, United States, 94305
2
Research Site
Aurora, Colorado, United States, 80045
3
Research Site
Boston, Massachusetts, United States, 02115
4
Research Site
Rochester, Minnesota, United States, 55905