Nicotinamide Riboside for Combined Pulmonary Hypertension
Mechanistic Study of Nicotinamide Riboside on NAD+ Biology in Individuals With Combined Pulmonary Hypertension
Recruiting
N/AInterventional Study
Pulmonary Hypertension
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 85
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
10 (estimated)
Sponsor
Vanderbilt University Medical Center · Other
Who this trial is looking for
This trial is looking for adults with a specific type of serious lung condition called combined pulmonary hypertension. Participants will take a dietary supplement and a placebo at different times to see if it helps improve their health.
Are You a Good Fit for This Trial?
Rules you outSevere allergic reaction to nicotinamide riboside
You may be able to join if
I am between 18 and 85 years old.
I have been diagnosed with combined pre-/post-capillary pulmonary hypertension.
I am in NYHA Class I - III.
I have had a qualifying heart test in the last 2 years.
I have a recent echocardiogram showing a certain heart function.
I have a stable medication regimen.
I can walk and perform a walk test.
You may not be able to join if
I have pulmonary hypertension due to congenital heart disease.
I cannot perform regular activities due to being wheelchair-bound or bed-bound.
I am pregnant.
I have a history of drug use related to pulmonary hypertension.
I have a history of cirrhosis.
I currently have cancer.
I have severe liver problems.
I have had a recent hospitalization.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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. Th…
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.
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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 RH…
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
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