Early Phase 1
N=5
Nicotinamide Riboside in LVAD Recipients
Heart Failure，Congestive · Heart Failure New York Heart Association Class IV · Mitochondrial Alteration
Bottom Line
View on ClinicalTrials.gov: NCT03727646 ↗Enrolled (actual)
5
Serious AEs
40.0%
Results posted
Sep 2024
Primary outcome: Primary: Number of Participates Experiencing Treatment-Emergent Adverse Events (Safety and Tolerability) — 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Nicotinamide riboside (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participates Experiencing Treatment-Emergent Adverse Events (Safety and Tolerability) |
2 | — |
| PRIMARY Pre/Post NR Comparison of Maximal Mitochondrial Respiration in PBMCs |
140.8; 317.8 | — |
| SECONDARY Effect of NR on Whole Blood NAD+ Levels |
40.625; 18.025 | — |
| SECONDARY Between-group Comparison of Mitochondrial Respiration (Seahorse Assay) in Isolated Peripheral Blood Mononuclear Cells (PBMCs) |
317.7895265 | — |
| SECONDARY Between-group Comparison of Whole Blood NAD+ Levels |
40.625 | — |
Summary
While preliminary data show that oral nicotinamide riboside (NR) supplementation increases myocardial levels of oxidized nicotine-adenine dinucleotide (NAD+) levels in mice, there has been no direct evidence that suggests oral NR increases NAD+ levels or improves mitochondrial function in human hearts. This Pilot Study is designed to obtain feasibility data for a planned, larger study testing the hypothesis that oral NR supplementation will increase myocardial NAD+ levels and improve cardiomyocyte mitochondrial function in participants with advanced heart failure planned for elective left ventricular assist device (LVAD) implantation. To demonstrate safety and feasibility of NR in this patient population, the investigators propose to enroll 5 participants planned for LVAD implantation in a Pilot Study of NR in which participants will receive NR, up-titrated over 3 days to a final NR dose of 1000mg twice daily. Blood and myocardial tissue analyses collected previously from age- and gender-matched LVAD recipients will serve as controls.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of advanced heart failure.
- Planned elective LVAD implantation surgery with patient agreements for candidacy in place as required by UWMC.
- Hospital inpatient at time of enrollment.
- Ability to undergo Study procedures.
- Willingness/ability to provide informed consent.
Exclusion Criteria
- Current smoking
- Receiving certain concurrent supplements (to be determined at discretion of the PI). Note that UWMC Nutrition Care standards call for a general multivitamin (1 tab PO daily) as part of the advanced heart failure therapy (AHFT) work-up.
- Known allergies to niacin or nicotinamide.
- Hepatic, renal, endocrine, or neurological disease that disqualify them from consideration for LVAD implantation.
- Inability to perform Study visits or procedures.
- Unwillingness/inability to provide informed consent.
- Women who are currently pregnant or who wish to become pregnant over the course of the study follow-up are not allowed to join this study. This exclusion is built into the LVAD candidate selection process.
Data sourced from ClinicalTrials.gov (NCT03727646). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.