10 Participants NeededMy employer runs this trial

Nicotinamide Riboside for Pulmonary Hypertension

TE
Overseen ByThomas E Strayer, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Vanderbilt University Medical Center

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a form of vitamin B3, nicotinamide riboside (NR), can benefit individuals with a specific type of high blood pressure in the lungs and heart, known as combined pre- and post-capillary pulmonary hypertension (CPH). CPH is a challenging condition that often leads to heart failure, and currently, no approved treatments exist. The study compares NR to a placebo to assess its effects on body markers related to cell energy and heart health, rather than directly addressing symptoms. Ideal participants are those diagnosed with CPH who can still walk, indicating that the condition affects but does not severely limit their daily activities. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could lead to new treatment options for CPH.

Do I have to stop taking my current medications for this trial?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should have a stable medication regimen for pulmonary hypertension or heart failure, with no more than one diuretic adjustment in the three months before joining the study.

What prior data suggests that nicotinamide riboside is safe for pulmonary hypertension?

Research has shown that nicotinamide riboside (NR) is generally safe for use. One study demonstrated that taking 2 grams of NR daily for 12 weeks was safe and significantly increased levels of NAD⁺, a key substance for cell energy, in patients with heart failure. Another study found no reports of moderate or severe side effects, even with high doses of NR, suggesting that NR is unlikely to cause serious side effects. As a type of vitamin B3 often used as a dietary supplement, NR's safety is further supported.12345

Why are researchers excited about this trial?

Nicotinamide riboside (NR) is unique because it targets pulmonary hypertension by boosting cellular energy and enhancing mitochondrial function. Unlike standard treatments like endothelin receptor antagonists or phosphodiesterase-5 inhibitors, which primarily work by relaxing blood vessels, NR offers a novel approach by addressing the underlying cellular health and energy production. Researchers are excited about NR because it has the potential to improve overall heart function and energy metabolism, which could lead to better outcomes for patients with pulmonary hypertension.

What evidence suggests that nicotinamide riboside might be an effective treatment for pulmonary hypertension?

Research suggests that nicotinamide riboside (NR) might help people with pulmonary hypertension (PH). In animal studies, NR repaired damage to blood vessels and the heart caused by PH by increasing NAD⁺ levels, a compound that helps cells produce energy and function properly. Other studies in humans have found that NR can raise NAD⁺ levels and lower oxidative stress, which can harm cells. Additionally, NR has been reported to lower systolic blood pressure and reduce inflammation, both of which benefit heart and lung health. While these findings are promising, NR is currently only used as a dietary supplement to support normal body functions, not as a proven treatment for PH. In this trial, participants will receive either NR or a placebo to evaluate its potential benefits for PH.12567

Who Is on the Research Team?

EL

Evan L Brittain, MD

Principal Investigator

VUMC

Are You a Good Fit for This Trial?

This trial is for adults aged 18–85 with a specific type of pulmonary hypertension (CPH), who can walk, have stable heart and lung function, and are on steady medications. People with certain other lung or heart diseases, severe liver or kidney problems, recent hospitalizations, pregnancy, or allergies to NR cannot join.

Inclusion Criteria

I am able to walk on my own and complete a walking test.
I am between 18 and 85 years old.
A qualifying Baseline RHC performed within 2 years of consent Clinical echocardiogram within the prior year with LVEF>/= 45%
See 3 more

Exclusion Criteria

I have PAH caused by drugs or toxins and am currently using those substances.
I have pulmonary hypertension caused by a heart defect, connective tissue disease, or inherited condition.
My lung function is below 60% and I have moderate or worse lung imaging issues.
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive nicotinamide riboside (NR) and placebo at different times to study the effects on biological and biochemical markers

15 weeks
Visits at Baseline, Week 6, Week 9, Week 15

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Nicotinamide Riboside (NR)

Trial Overview

The study tests nicotinamide riboside (NR), a form of vitamin B3 supplement, compared to placebo in people with CPH. Each participant will receive both NR and placebo at different times to see how NR affects body chemistry related to cell energy—not symptoms.

How Is the Trial Designed?

2

Treatment groups

Active Control

Placebo Group

Group I: Nicotinamide riboside (NR)Active Control1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials
922
Recruited
939,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

Citations

Mechanistic Study of Nicotinamide Riboside on NAD+ ...

Pulmonary hypertension (PH) is a serious condition that puts strain on the heart and lungs and often leads to frequent hospital stays and ...

Nicotinamide Phosphoribosyltransferase Promotes Pulmonary ...

Our data provide evidence that NAMPT plays a role in pulmonary vascular remodeling and its inhibition could be a potential therapeutic target for PAH. Keywords: ...

Nicotinamide Riboside Reverses Pulmonary Hypertension

Preclinical study found nicotinamide riboside (NR) reverses vascular and heart damage in pulmonary hypertension.

Nicotinamide riboside combined with exercise to treat ... - PMC

For example, 6 weeks of 1000 mg per day of oral NR supplementation was reported to safely elevate NAD + levels and reduce SBP and arterial ...

What is really known about the effects of nicotinamide ...

The results showed a dose-dependent increase of NAD+ in whole blood as well as increases of NAM and MeNAM in plasma and of MeNAM and Me2PY in ...

Nicotinamide Phosphoribosyltransferase Promotes ...

Our data provide evidence that NAMPT plays a role in pulmonary vascular remodeling and that its inhibition could be a potential therapeutic target for pulmonary ...

Safety and Tolerability of Nicotinamide Riboside in Heart ...

In in this study, NR at 2 g/d over 12 weeks was safe, well tolerated, and significantly increased whole blood NAD+ levels in ambulatory stage C HFrEF patients.