Mechanistic Studies of Nicotinamide Riboside in Human Heart Failure

What Was Tested

This registered early phase 1 trial tested NAD+.

It had two arms (groups): Nicotinamide riboside (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug and other.

More on the Plan

To this end, the study has the following specific aims: Aim 1: Randomize 40 participants undergoing elective LVAD placement into a double-blind, placebo-controlled study of NR vs. placebo at an NR:placebo ratio of 2:1. 1.

Final labs will be drawn on the day of surgery, and samples of fresh cardiac tissue removed from the left ventricular apex during LVAD implantation surgery will be collected in the operating room.

Aim 2: Determine the effect of NR vs. placebo on NAD(H) levels, mitochondrial function and its regulation through epigenetic modifications in the failing myocardium. 1.

Assess mitochondrial morphology and function in cardiac tissue using electron microscopy (EM) and isolated mitochondria. 3.

Who Took Part

Enrollment: 32 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Scheduled (or soon to be scheduled) for elective LVAD implantation. Age \>18 years.

The full record lists 4 inclusion and 14 exclusion criteria; among the exclusions: 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).

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the NAD+ group and the comparison group should start out alike.

The NAD+ group and the comparison group ran side by side rather than switching.

As a double-blind NAD+ study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2020-09-26 with completion listed for 2024-11-30.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

It also tracked 7 secondary outcomes, for example Between-group comparisons of myocardial NAD(H) levels, Between-group comparisons of myocardial mitochondrial respiratory function, Between-group comparisons of myocardial mitochondrial morphology, Between-group comparisons of myocardial protein acetylation, Between-group comparisons of myocardial gene expression by RNA-seq and the myocardial epigenome by ATAC-seq and Between-group comparisons of inflammatory markers in myocardium.

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of NAD+ in 32 people.

Its size is small, so on its own it can only give an early look.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the NAD+ compound page, all human trials.