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 @ 3:35 PM
Ignite Modification Date:
2025-12-24 @ 3:35 PM
NCT ID:
NCT05981092
Eligibility Criteria:
Inclusion Criteria:
* 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 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05981092
Study Brief:
Protocol Section:
NCT05981092