Mechanistic Studies of Nicotinamide Riboside in Human Heart Failure
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 its metabolite, nicotinamide adenine dinucleotide (NAD+, NADH). This Study will address a key gap in current knowledge by assessing the mechanisms through which raising blood and myocardial NAD+ levels in humans mediates changes in mitochondrial function, protein and epigenetic modifications, as well as inflammation. Human myocardium will be obtained after 4-14 days of oral NR supplementation from advanced heart failure patients undergoing elective left ventricular assist device (LVAD) implantation. Positive results would provide evidence to proceed with further studies of NR as a mitochondria-targeted metabolic therapy in heart failure.
Conditions:
🦠 Heart Failure, Systolic 🦠 Heart Failure NYHA Class IV 🦠 Metabolic Disturbance
🗓️ Study Start (Actual) 26 September 2020
🗓️ Primary Completion (Estimated) 31 March 2025
✅ Study Completion (Estimated) 31 July 2025
👥 Enrollment (Estimated) 40
🔬 Study Type INTERVENTIONAL
📊 Phase EARLY_PHASE1
Locations:
📍 Seattle, Washington, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 18 August 2020
  • First Submitted that Met QC Criteria 21 August 2020
  • First Posted 27 August 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 17 July 2023
  • Last Update Posted 19 July 2023
  • Last Verified July 2023