Pulmonary HypertensionNCT07563322
Mechanistic Study of Nicotinamide Riboside on NAD+ Biology in Individuals With Combined Pulmonary Hypertension
A study testing Nicotinamide Riboside (NR) in people with Pulmonary Hypertension, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- Nicotinamide Riboside (NR)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2026to 30 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37203
Thomas E Strayer, PhD, 615-936-0156, thomas.e.strayer@vumc.org
Evan L Brittain, MD
About this study
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.
Read more
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.
- Conditions
- Pulmonary Hypertension
- Being tested
- Nicotinamide Riboside (NR), Placebo
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotinamide Riboside (NR)Dietary supplement
Participants will be randomized to receive either 1000mg NR Daily or a placebo for 6 weeks, followed by a 3-week washout period. After this, they will receive the alternate treatment for an additional 6 weeks.
PlaceboDrug
Participants will be randomized to receive either NR or a placebo for 6 weeks, followed by a 3-week washout period. After this, they will receive the alternate treatment for an additional 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo portion of the trial Receives: Drug: Placebo |
| Nicotinamide riboside (NR) | Active comparator | NR Portion of the trial Receives: Dietary Supplement: Nicotinamide Riboside (NR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical: Change in NADH:Ubiquinone Oxidoreductase Subunit B7
Measured: Baseline, Week 6, Week 9, Week 15
Exploratory physiological measure: Change in 6-minute walk distance
The 6MWT measures the distance (in meters), a participant can walk at a comfortable speed on a flat, hard surface in 6 minutes. The intent of the 6MWD test is to evaluate exercise capacity associated with carrying out daily physical activities.
Measured: Baseline, Week 6, Week 9, Week 15
Secondary outcomes (13)
Change in N-terminal pro-B-type natriuretic peptide Values
Measured: Baseline, Week 6, Week 9, Week 15
Change in New York Heart Association Functional classification (NYHA)
The New York Heart Association (NYHA) functional classification is a widely used system for assessing the severity of heart failure based on symptoms and their impact on physical activity. It is divided into four classes: Class I includes individuals with no limitations on physical activity and no symptoms during ordinary activities; Class II includes individuals with mild limitations on physical activity, where ordinary physical activity causes fatigue, shortness of breath, or other symptoms; Class III includes individuals with marked limitations on physical activity, where less-than-ordinary activity results in symptoms; and Class IV includes individuals who are unable to engage in any physical activity without discomfort and may experience symptoms even at rest. The NYHA functional class will be evaluated at Baseline and Visit 2. The NYHA functional classification is an ordinal scale ranging from Class I to Class IV, with lower class numbers indicating better functional status. Imp
Measured: Baseline, Week 6, Week 9, Week 15
Change in Empahsis-10 score
The emPHasis-10 is a short and easy questionnaire that consists of 10 items that address breathlessness, fatigue, control, and confidence. Each item is scored on a semantic differential six-point scale (0-5), with contrasting adjectives at each end. A total emPHasis-10 score is derived using simple aggregation of the 10 items. emPHasis-10 scores range from 0 to 50, higher scores indicate worse quality of life
Measured: Baseline, Week 6, Week 9, Week 15
Change in SF-36 Score
The SF36 includes one multi-item scale that assesses eight health concepts: 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical and emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions. Remote subjects will complete the SF-36 at baseline and each subsequent visit during the study. Each SF-36 domain is scored using a standardized transformation to a 0-100 scale, with higher scores indicating better health status (i.e., fewer limitations, less pain, greater well-being, and higher vitality). Improvements over time are reflected by increases in domain scores relative to baseline.
Measured: Baseline, Week 6, Week 9, Week 15
Change in Minnesota Living with Heart Failure Questionnaire
The MLHF (Minnesota Living with Heart Failure Questionnaire) is a widely used disease-specific instrument designed to assess the impact of heart failure on an individual's quality of life. The MLHF includes 21 items that evaluate various aspects of physical, emotional, and social functioning as affected by heart failure. It focuses on areas such as 1) physical limitations due to heart failure symptoms; 2) the emotional impact of living with heart failure; 3) interference with social activities; 4) effects on usual daily activities; and 5) overall quality of life as perceived by the patient. Participants will complete the MLHF at baseline and during each subsequent visit to monitor changes in their quality of life throughout the study. Each MLHF item is scored on a 6-point Likert scale ranging from 0 ("no impact") to 5 ("very much"), reflecting how much heart failure has affected the patient during the past month. Item scores are summed to produce a total score ranging from 0 to 105, w
Measured: Baseline, Week 6, Week 9, Week 12
Change in Tricuspid annular plane systolic excursion
Measured: Baseline, Week 6, Week 9, Week 15
Change in RV Fractional Area
Right ventricular fractional area change (RV FAC) is a non-invasive measure of right ventricular systolic function assessed using transthoracic echocardiography. RV FAC is calculated from standard echocardiographic images by comparing right ventricular area during diastole and systole. Higher RV FAC values indicate better right ventricular function. Change in RV FAC from baseline will be used to assess changes in right ventricular systolic performance during the study.
Measured: Baseline, Week 6, Week 9, Week 15
Change in RV Longitudinal Strain
Right ventricular longitudinal strain is a non-invasive measure of right ventricular myocardial function assessed using transthoracic echocardiography with strain analysis. RV longitudinal strain quantifies myocardial deformation of the right ventricle during systole. More negative strain values indicate better right ventricular systolic function. Change in RV longitudinal strain from baseline will be used to assess changes in right ventricular myocardial performance during the study.
Measured: Baseline, Week 6, Week 9, Week 15
Incidence of Treatment-Emergent Adverse Event
This will be a measure of adverse events in the study
Measured: Baseline, Week 6, Week 9, Week 15
Number of patients with an incidence of death
Measured: Week 16
Change in NAD+
Measured: Baseline, 6-weeks, 9-weeks, 12-weeks
,Change in NADH.
Measured: Baseline, 6-week, 9-week, 12-week
Change in Nicotinamide Mononucleotide
Measured: Baseline, 6-week, 9 week, 15 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start9 Apr 2026
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Evan Brittain, Vanderbilt University Medical Center
- Investigators
- Evan L Brittain, MD, Principal investigator, VUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07563322
- Sponsor's protocol ID
- 260020
- Other IDs
- R01HL163960
- Status last verified
- Apr 2026
- First submitted
- 22 Apr 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will provide a data dictionary/dataset available upon reasonable request as needed.
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanistic Study of Nicotinamide Riboside on NAD+ Biology in Individuals With Combined Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT07563322
- Acronym / sponsor ID
- 260020
- Conditions
- Pulmonary Hypertension
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 9 Apr 2026 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 4 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo portion of the trial |
| Nicotinamide riboside (NR) | Active comparator | Dietary Supplement: Nicotinamide Riboside (NR)NR Portion of the trial |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotinamide Riboside (NR)Participants will be randomized to receive either 1000mg NR Daily or a placebo for 6 weeks, followed by a 3-week washout period. After this, they will receive the alternate treatment for an additional 6 weeks. | Dietary supplement | Nicotinamide riboside (NR) |
| PlaceboParticipants will be randomized to receive either NR or a placebo for 6 weeks, followed by a 3-week washout period. After this, they will receive the alternate treatment for an additional 6 weeks. | Drug | Placebo |
Primary outcome
Biochemical: Change in NADH:Ubiquinone Oxidoreductase Subunit B7
Time frame: Baseline, Week 6, Week 9, Week 15
Exploratory physiological measure: Change in 6-minute walk distance
Time frame: Baseline, Week 6, Week 9, Week 15
The 6MWT measures the distance (in meters), a participant can walk at a comfortable speed on a flat, hard surface in 6 minutes. The intent of the 6MWD test is to evaluate exercise capacity associated with carrying out daily physical activities.
13 secondary outcomes
Change in N-terminal pro-B-type natriuretic peptide Values
Time frame: Baseline, Week 6, Week 9, Week 15
Change in New York Heart Association Functional classification (NYHA)
Time frame: Baseline, Week 6, Week 9, Week 15
Change in Empahsis-10 score
Time frame: Baseline, Week 6, Week 9, Week 15
Change in SF-36 Score
Time frame: Baseline, Week 6, Week 9, Week 15
Change in Minnesota Living with Heart Failure Questionnaire
Time frame: Baseline, Week 6, Week 9, Week 12
Change in Tricuspid annular plane systolic excursion
Time frame: Baseline, Week 6, Week 9, Week 15
Change in RV Fractional Area
Time frame: Baseline, Week 6, Week 9, Week 15
Change in RV Longitudinal Strain
Time frame: Baseline, Week 6, Week 9, Week 15
Incidence of Treatment-Emergent Adverse Event
Time frame: Baseline, Week 6, Week 9, Week 15
Number of patients with an incidence of death
Time frame: Week 16
Change in NAD+
Time frame: Baseline, 6-weeks, 9-weeks, 12-weeks
,Change in NADH.
Time frame: Baseline, 6-week, 9-week, 12-week
Change in Nicotinamide Mononucleotide
Time frame: Baseline, 6-week, 9 week, 15 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: Yes. We will provide a data dictionary/dataset available upon reasonable request as needed.
Related trials for Pulmonary Hypertension
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
Pulmonary Arterial Hypertension
RecruitingObservational study
Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
Pulmonary Disease, Pulmonary Hypertension
Active, not recruitingPhase 1
Study of Intravenous ZMA001 in Healthy Subjects
Pulmonary Arterial Hypertension PAH
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Evan L Brittain, MD principal investigator
VUMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotinamide Riboside (NR) in people with Pulmonary Hypertension, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas E Strayer, PhD (615-936-0156, thomas.e.strayer@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical: Change in NADH:Ubiquinone Oxidoreductase Subunit B7 (time frame: Baseline, Week 6, Week 9, Week 15). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.