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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 85 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how nicotinamide riboside (NR), a form of vitamin B3, affects cell energy and other body markers. It is for adults with combined pulmonary hypertension (CPH), a type of high blood pressure in the lungs. Participants take NR and a placebo at different times; the study does not test whether NR improves symptoms or health outcomes.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 to 85.
  • Have CPH confirmed by heart tests: average lung artery pressure above 20 mmHg, wedge pressure above 15 mmHg, and resistance to blood flow at least 3 Wood units.
  • Have NYHA Class I–III heart symptoms, meaning no to marked limits on activity, but comfort at rest.
  • Had a qualifying right-heart catheter test, which measures pressure inside the heart and lung vessels, within 2 years before consent.
  • Had a heart ultrasound within the past year showing a left-heart pumping measure (LVEF) of at least 45%.
  • Have stable medicines for lung blood pressure or heart failure, with no more than one change to water pills in the past 3 months.
  • Can walk and complete the walking test.

Who can't join

  • Have lung high blood pressure caused by a heart defect present at birth, connective tissue disease, or an inherited condition; or have drug- or toxin-related lung high blood pressure with current drug use.
  • Cannot do regular activity because of wheelchair use, being bed-bound, needing a cane or walker, chest pain, arthritis, or another condition.
  • Are pregnant or have active cancer.
  • Have current or past liver scarring (cirrhosis), moderate to severe liver problems (Child-Pugh B or C), or liver blood tests called ALT or AST above 3 times the normal upper limit.
  • Have a kidney filtering rate below 30, or a breathing test result (FEV1) below 60% of expected with more than mild changes on lung images.
  • Are in another study of an experimental product, finished one within 30 days before screening, or were hospitalized for any reason within 30 days before Day 1.
  • Have had a severe allergic reaction or sensitivity to NR.
  • Have no known change (mutation) in the NDUFB7 gene, as listed in the study's exclusion rules.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Aged \>/= 18 to 85 years of age * Diagnosis of Combined pre-/post-capillary PH (CPH) defined as mean pulmonary artery pressure \>20mmHg, pulmonary capillary wedge pressure \>15mmHg, and pulmonary vascular resistance ³3 Wood units * NYHA Class I - III * A qualifying Baseline RHC performed within 2 years of consent Clinical echocardiogram within the prior year with LVEF\>/= 45% * Stable PH-specific and/or HF medication regimen and ≤1 diuretic adjustment within the three months prior to enrollment. * Ambulatory - able to perform the walk test Exclusion Criteria: * Pulmonary hypertension due to congenital heart disease, connective tissue disease, or heritable pulmonary arterial hypertension * Prohibited from regular activity due to wheelchair bound status, bed-bound status, reliance on a cane/walker, activity-limiting angina, activity-limiting osteoarthritis, or other conditions that limit activity * Pregnancy * Drug and toxin-associated PAH patients with active drug use * Prior or active diagnosis of cirrhosis * Active Malignancy * Patients with evidence of moderate to severe hepatic impairment, defined as Child-Pugh Class B or C, or with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than 3 times the upper limit of normal (ULN), should be excluded * eGFR by MDRD \<30mL/mi * FEV1\< 60% predicted with more than mild abnormalities on lung imaging Current enrollment in or completion of any other investigational product study within 30 days of Screening. * Hospitalization for any indication within 30 days of Day 1. * History of severe allergic or anaphylactic reaction or hypersensitivity to NR * No known mutation in NDUFB7

Study sites (1)

TN