CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03423342
NCT03423342Phase 2Completed

Safety and Tolerability of the Nutritional Supplement, Nicotinamide Riboside, in Systolic Heart Failure

University of Washington·interventional·Posted Feb 6, 2018·Updated Nov 16, 2022

In Brief

A Phase 2 clinical trial evaluating nicotinamide riboside and Placebo for Heart Failure, Systolic. Completed, enrolled 30 participants across 1 site.

Detailed Summary

Mitochondrial dysfunction has been implicated in heart failure (HF), and is associated with an imbalance in intracellular ratio of reduced nicotinamide-adenine dinucleotide (NADH) to oxidized nicotinamide-adenine dinucleotide (NAD), or the NADH/NAD ratio. In mouse models of HF, we have found that normalization of the NADH/NAD, through supplementation with NAD+ precursors, is associated with improvement in cardiac function. This Study will randomize participants with systolic HF (ejection fraction ≤40%) to treatment with the NAD precursor, nicotinamide riboside (NR) or matching placebo, uptitrated to a final oral dose of 1000mg twice daily, to determine the safety and tolerability of NR in participants with systolic HF.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 6, 2018
Enrollment StartMay 19, 2016
Primary CompletionApr 11, 2019
Study CompletionJun 30, 2019
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 8.4 years ago

Interventions

nicotinamide ribosidedietary

nicotinamide riboside capsule

Placebodrug

matching placebo capsule