Nicotinamide Riboside in LVAD Recipients

What Was Tested

This registered early phase 1 trial tested NAD+.

It had two arms (groups): Open-label nicotinamide riboside (experimental) and Baseline controls (no intervention).

Patients previously receiving LVADs, in whom blood and myocardial tissue assays for NAD+ levels and mitochondrial function were performed.

The registry classes the interventions as dietary supplement.

More on the Plan

This Pilot Study will examine the following Aims: Aim 1: Enroll 5 participants scheduled for elective left ventricular assist device (LVAD) placement into an open-label study of nicotinamide riboside (NR). a.

On the morning of LVAD implantation Surgery (Day 5 or later), participants will have final labs drawn.

Samples of fresh cardiac tissue removed from the left ventricular apex during LVAD implantation surgery will be collected in the operating room.

The maximum duration of NR administration will be capped at 14 days.

Who Took Part

The registry lists 5 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: 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.

The full record lists 5 inclusion and 7 exclusion criteria; among the exclusions: current smoking; known allergies to niacin or nicotinamide; hepatic, renal, endocrine, or neurological disease that disqualify them from consideration for lvad implantation.

How the Study Was Run

The set-up was non-randomized, single-group and single-blind.

Only one side, usually the participants, was kept unaware of whether NAD+ was given.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

Those kept unaware of assignments: outcomes assessor.

It started in 2018-09-26 with completion listed for 2018-11-26.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of Participates Experiencing Treatment-Emergent Adverse Events (Safety and Tolerability) (time frame: from Day 1 receiving NR to the day before LVAD surgery (between Day 6-Day 14)). Pre/Post NR Comparison of Maximal Mitochondrial Respiration in PBMCs (time frame: from Day 1 receiving NR to the day before LVAD surgery (between Day 6-Day 14)).

It also tracked 3 secondary outcomes, for example Effect of NR on Whole Blood NAD+ Levels, Between-group Comparison of Mitochondrial Respiration (Seahorse Assay) in Isolated Peripheral Blood Mononuclear Cells (PBMCs) and Between-group Comparison of Whole Blood NAD+ Levels.

What This Means in Plain Language

Put simply, this is a early phase 1, non-randomized trial of NAD+ in 5 people.

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

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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