Status:
ACTIVE_NOT_RECRUITING
Mechanistic Studies of Nicotinamide Riboside in Human Heart Failure
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Heart Failure, Systolic
Heart Failure NYHA Class IV
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
Preliminary animal studies by ourselves and others suggest that the dietary supplement, nicotinamide riboside (NR), may improve cardiac function in heart failure (HF) by increasing cellular levels of ...
Detailed Description
To definitively demonstrate the effects of increasing NAD+ levels in HF patients, this randomized, placebo-controlled trial of NR in 40 participants scheduled for elective LVAD surgery with the underl...
Eligibility Criteria
Inclusion
- 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
- Meet clinical and socioeconomic screening criteria for elective LVAD implantation by the University of Washington Mechanical Circulatory Support Program
- Scheduled (or soon to be scheduled) for elective LVAD implantation
- Age \>18 years
Exclusion
- End-stage heart failure due to causes other than ischemic or non-ischemic cardiomyopathy (e.g., valvular, hypertrophic or infiltrative cardiomyopathies).
- Disease that disqualifies from consideration for LVAD implantation by the University of Washington program:
- Cirrhosis as evidenced by liver biopsy
- Irreversible, severe renal disease (estimated glomerular filtration rate (eGFR) \<30) or on chronic dialysis
- Untreated thyroid disease (hyper- or hypo-thyroidism)
- Severe complications of diabetes, such as diabetes-related amputation, severe retinopathy, peripheral neuropathy or diabetic renal disease (eGFR \<30)
- Tissue physiology or other factors that, in the opinion of the Cardiac Surgeons, make the patient at unacceptably high risk for adverse outcomes.
- Non-compliance with current treatments, including failure to follow prescribed therapies, such as medications, clinic visits, diagnostic testing and behavioral contracts
- Active use/abuse of illicit substances
- Lack of adequate caregiver support to help patient manage LVAD
- Known allergies to niacin, nicotinamide or warfarin
- Inability to perform Study visits or procedures
- Unwillingness/inability to provide informed consent.
- Participants considered by the attending cardiologist and/or the investigator to be unsuitable for the study
Key Trial Info
Start Date :
September 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2025
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04528004
Start Date
September 26 2020
End Date
July 31 2025
Last Update
March 25 2025
Active Locations (1)
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1
University of Washington
Seattle, Washington, United States, 98195