NCT07563322 Mechanistic Study of Nicotinamide Riboside on NAD+ Biology in Individuals With Combined Pulmonary Hypertension
| NCT ID | NCT07563322 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vanderbilt University Medical Center |
| Condition | Pulmonary Hypertension |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2026-04-09 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2026-04-09 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Evan L Brittain, MD
PRINCIPAL INVESTIGATOR
VUMC
Frequently Asked Questions
Who can join the NCT07563322 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Pulmonary Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07563322 currently recruiting?
Yes, NCT07563322 is actively recruiting participants. Contact the research team at thomas.e.strayer@vumc.org for enrollment information.
Where is the NCT07563322 trial being conducted?
This trial is being conducted at Nashville, United States.
Who is sponsoring the NCT07563322 clinical trial?
NCT07563322 is sponsored by Vanderbilt University Medical Center. The principal investigator is Evan L Brittain, MD at VUMC. The trial plans to enroll 10 participants.