Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
NCT07563322

Mechanistic Study of Nicotinamide Riboside on NAD+ Biology in Individuals With Combined Pulmonary Hypertension

Led by Vanderbilt University Medical Center · Updated on 2026-05-04

10

Participants Needed

1

Research Sites

68 weeks

Total Duration

On this page

Sponsors

V

Vanderbilt University Medical Center

Lead Sponsor

N

National Heart, Lung, and Blood Institute (NHLBI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Pulmonary hypertension (PH) is a serious condition that puts strain on the heart and lungs and often leads to frequent hospital stays and shortened life expectancy. The most common cause is heart disease affecting the left side of the heart. A particularly high-risk form, called combined pre- and post-capillary pulmonary hypertension (CPH), occurs in about one in four people with heart failure. There are currently no approved treatments for CPH, and many patients develop right-sided heart failure and die earlier than expected. This study is based on a new approach that uses advanced computer methods to analyze a patient's unique biology and identify potential drug targets. Using this method, we identified nicotinamide riboside (NR) as a promising option for people with CPH. NR is a form of vitamin B3 that helps the body make NAD⁺, a substance essential for how cells produce energy and stay healthy. NAD⁺ plays an important role in how heart and blood vessel cells function. Previous research in animals suggests NR may help improve blood vessel changes in the lungs and support heart function. NR has also shown potential benefits in human studies related to cell energy, mitochondrial health, and reducing oxidative stress. In this study, NR is used only as a dietary supplement that supports normal body processes, not as a proven treatment. The investigators will conduct a small, carefully controlled study in which participants receive NR and a placebo at different times. The goal is to understand how NR affects biological and biochemical markers in the body, not to test whether it improves symptoms or outcomes. Any clinical measurements are included only to help interpret the biological effects.

CONDITIONS

Official Title

Mechanistic Study of Nicotinamide Riboside on NAD+ Biology in Individuals With Combined Pulmonary Hypertension

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 to 85 years
  • Diagnosed with combined pre- and post-capillary pulmonary hypertension (CPH) defined by specific heart pressure and resistance measurements
  • New York Heart Association (NYHA) Class I to III
  • Qualifying right heart catheterization done within 2 years of consent
  • Clinical echocardiogram within the past year showing left ventricular ejection fraction of 45% or higher
  • Stable medication regimen for pulmonary hypertension and/or heart failure with no more than one diuretic adjustment in the past 3 months
  • Ambulatory and able to perform a walk test
Not Eligible

You will not qualify if you...

  • Pulmonary hypertension caused by congenital heart disease, connective tissue disease, or heritable pulmonary arterial hypertension
  • Unable to perform regular activity due to wheelchair use, bed-bound status, use of cane/walker, or activity-limiting conditions such as angina or osteoarthritis
  • Pregnant
  • Active drug use related to drug and toxin-associated pulmonary arterial hypertension
  • Prior or current diagnosis of cirrhosis
  • Active cancer
  • Moderate to severe liver impairment (Child-Pugh Class B or C) or liver enzyme levels more than 3 times the upper limit of normal
  • Estimated glomerular filtration rate (eGFR) less than 30 mL/min
  • Forced expiratory volume in 1 second (FEV1) less than 60% predicted with significant lung abnormalities
  • Participation in another investigational study within 30 days before screening
  • Hospitalization for any reason within 30 days before day 1
  • History of severe allergic or anaphylactic reaction to nicotinamide riboside
  • Known mutation in NDUFB7 gene

AI-Screening

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Trial Site Locations

Total: 1 location

1

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37203

Actively Recruiting

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Research Team

T

Thomas E Strayer, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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