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 @ 7:58 PM
Ignite Modification Date:
2025-12-24 @ 7:58 PM
NCT ID:
NCT04528004
Eligibility Criteria:
Inclusion Criteria:
1. End-stage heart failure due to ischemic or non-ischemic cardiomyopathy
a. If implanted for destination therapy indication, must have New Your Heart Association (NYHA) Class IV Heart Failure AND left ventricular ejection fraction (LVEF) \<25% OR maximum minute consumption of oxygen (VO2) \<14 OR on requirement for continuous intravenous inotropes
2. Meet clinical and socioeconomic screening criteria for elective LVAD implantation by the University of Washington Mechanical Circulatory Support Program
3. Scheduled (or soon to be scheduled) for elective LVAD implantation
4. Age \>18 years
Exclusion Criteria:
1. End-stage heart failure due to causes other than ischemic or non-ischemic cardiomyopathy (e.g., valvular, hypertrophic or infiltrative cardiomyopathies).
2. Disease that disqualifies from consideration for LVAD implantation by the University of Washington program:
1. Cirrhosis as evidenced by liver biopsy
2. Irreversible, severe renal disease (estimated glomerular filtration rate (eGFR) \<30) or on chronic dialysis
3. Untreated thyroid disease (hyper- or hypo-thyroidism)
4. Severe complications of diabetes, such as diabetes-related amputation, severe retinopathy, peripheral neuropathy or diabetic renal disease (eGFR \<30)
3. Tissue physiology or other factors that, in the opinion of the Cardiac Surgeons, make the patient at unacceptably high risk for adverse outcomes.
4. Non-compliance with current treatments, including failure to follow prescribed therapies, such as medications, clinic visits, diagnostic testing and behavioral contracts
5. Active use/abuse of illicit substances
6. Lack of adequate caregiver support to help patient manage LVAD
7. Known allergies to niacin, nicotinamide or warfarin
8. Inability to perform Study visits or procedures
9. Unwillingness/inability to provide informed consent.
10. Participants considered by the attending cardiologist and/or the investigator to be unsuitable for the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04528004
Study Brief:
Protocol Section:
NCT04528004