Nicotinamide riboside for combined pulmonary hypertension

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.