NCT04528004Active, not recruitingEarly phase 1
Mechanistic Studies of Nicotinamide Riboside in Human Heart Failure
Source: ClinicalTrials.gov · Last updated 25 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 32 (actual)
- First submitted
- 18 Aug 2020
- Start date
- 26 Sept 2020
- Primary completion date
- 30 Nov 2024
- Lead sponsor
- University of Washington
- Diseases
- Heart failure
- NCT number
- NCT04528004
What you commit to
- Study type: Interventional · Early phase 1
- Participants enrolled: 32
- From 26 Sept 2020 to the primary completion date, 30 Nov 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- End-stage heart failure due to causes other than ischemic or non-ischemic cardiomyopathy (e.g., valvular, hypertrophic or infiltrative cardiomyopathies).
- 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
- Known allergies to niacin, nicotinamide or warfarin
Lab values
- 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)
Other
- Active use/abuse of illicit substances
- Lack of adequate caregiver support to help patient manage LVAD
- 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
Who the study is looking for
- End-stage heart failure due to ischemic or non-ischemic cardiomyopathy
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Washington Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.