Nicotinamide riboside for combined pulmonary hypertension
Mechanistic Study of Nicotinamide Riboside on NAD+ Biology in Individuals With Combined Pulmonary Hypertension
This study tests whether nicotinamide riboside (a form of vitamin B3 that raises NAD+) can help adults with combined pre- and post-capillary pulmonary hypertension (CPH).
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT07563322 on ClinicalTrials.gov |
What this trial studies
Researchers used computational methods to nominate nicotinamide riboside (NR), a NAD+ precursor, as a candidate therapy for combined pre- and post-capillary pulmonary hypertension (CPH). In a randomized, placebo-controlled design at Vanderbilt University Medical Center, ambulatory adults aged 18–85 with hemodynamically confirmed CPH and LVEF ≥45% receive NR or placebo while continuing stable heart and pulmonary medications. Investigators will measure effects on NAD+ biology alongside clinical outcomes such as walk distance, symptoms, echocardiography, and catheterization-derived hemodynamics. The trial excludes patients with certain causes of pulmonary arterial hypertension, non-ambulatory status, pregnancy, or unstable therapies.
Who should consider this trial
Good fit: Ambulatory adults aged 18–85 with hemodynamically confirmed combined pre- and post-capillary pulmonary hypertension (mean PAP >20 mmHg, PCWP >15 mmHg, PVR ≥3 Wood units), NYHA class I–III, LVEF ≥45%, and a stable medication regimen are the ideal candidates.
Not a fit: Patients with PH due to congenital heart disease, connective tissue disease, heritable or drug/toxin-associated PAH, those who are non-ambulatory, pregnant, or who have unstable medical therapy are unlikely to be eligible or to receive benefit from this intervention.
Why it matters
Potential benefit: If successful, NR could raise NAD+ levels and improve cellular energy in heart and lung vessels, which might reduce symptoms or slow progression of CPH.
How similar studies have performed: Small human studies of NAD+ precursors like NR have shown safety and increases in NAD+ levels, but NR has not been proven effective for combined PH and this application is largely novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Nashville, Tennessee
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Evan L Brittain, MD — Vumc
- Study coordinator: Thomas E Strayer, PhD
- Email: thomas.e.strayer@vumc.org
- Phone: 615-936-0156
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.