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Mechanistic Study of Nicotinamide Riboside on NAD+ Biology in Individuals With Combined Pulmonary Hypertension

28 апреля 2026 г. обновлено: Evan Brittain, Vanderbilt University Medical Center

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.

Обзор исследования

Статус

Рекрутинг

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Оцененный)

10

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

  • Имя: Thomas E Strayer, PhD
  • Номер телефона: 615-936-0156
  • Электронная почта: thomas.e.strayer@vumc.org

Места учебы

  • Соединенные Штаты
    • Tennessee
      • Nashville, Tennessee, Соединенные Штаты, 37203
        • Рекрутинг
        • Vanderbilt University Medical Center
        • Главный следователь:
          • Evan L Brittain, MD
        • Контакт:
          • Thomas E Strayer, PhD
          • Номер телефона: 615-936-0156
          • Электронная почта: thomas.e.strayer@vumc.org

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Нет

Описание

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

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Назначение кроссовера
  • Маскировка: Двойной

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Плацебо Компаратор: Placebo
Placebo portion of the trial
Лекарство: Placebo
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.
Активный компаратор: Nicotinamide riboside (NR)
NR Portion of the trial
Диетическая добавка: 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.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Biochemical: Change in NADH:Ubiquinone Oxidoreductase Subunit B7
Временное ограничение: Baseline, Week 6, Week 9, Week 15
Baseline, Week 6, Week 9, Week 15
Exploratory physiological measure: Change in 6-minute walk distance
Временное ограничение: 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.
Baseline, Week 6, Week 9, Week 15

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Change in N-terminal pro-B-type natriuretic peptide Values
Временное ограничение: Baseline, Week 6, Week 9, Week 15
Baseline, Week 6, Week 9, Week 15
Change in New York Heart Association Functional classification (NYHA)
Временное ограничение: Baseline, Week 6, Week 9, Week 15
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
Baseline, Week 6, Week 9, Week 15
Change in Empahsis-10 score
Временное ограничение: Baseline, Week 6, Week 9, Week 15
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
Baseline, Week 6, Week 9, Week 15
Change in SF-36 Score
Временное ограничение: Baseline, Week 6, Week 9, Week 15
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.
Baseline, Week 6, Week 9, Week 15
Change in Minnesota Living with Heart Failure Questionnaire
Временное ограничение: Baseline, Week 6, Week 9, Week 12
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
Baseline, Week 6, Week 9, Week 12
Change in Tricuspid annular plane systolic excursion
Временное ограничение: Baseline, Week 6, Week 9, Week 15
Baseline, Week 6, Week 9, Week 15
Change in RV Fractional Area
Временное ограничение: Baseline, Week 6, Week 9, Week 15
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.
Baseline, Week 6, Week 9, Week 15
Change in RV Longitudinal Strain
Временное ограничение: Baseline, Week 6, Week 9, Week 15
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.
Baseline, Week 6, Week 9, Week 15
Incidence of Treatment-Emergent Adverse Event
Временное ограничение: Baseline, Week 6, Week 9, Week 15
This will be a measure of adverse events in the study
Baseline, Week 6, Week 9, Week 15
Number of patients with an incidence of death
Временное ограничение: Week 16
Week 16
Change in NAD+
Временное ограничение: Baseline, 6-weeks, 9-weeks, 12-weeks
Baseline, 6-weeks, 9-weeks, 12-weeks
,Change in NADH.
Временное ограничение: Baseline, 6-week, 9-week, 12-week
Baseline, 6-week, 9-week, 12-week
Change in Nicotinamide Mononucleotide
Временное ограничение: Baseline, 6-week, 9 week, 15 week
Baseline, 6-week, 9 week, 15 week

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Vanderbilt University Medical Center

Соавторы

National Heart, Lung, and Blood Institute (NHLBI)

Следователи

  • Главный следователь: Evan L Brittain, MD, VUMC

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

9 апреля 2026 г.

Первичное завершение (Оцененный)

30 апреля 2027 г.

Завершение исследования (Оцененный)

30 июля 2027 г.

Даты регистрации исследования

Первый отправленный

22 апреля 2026 г.

Впервые представлено, что соответствует критериям контроля качества

28 апреля 2026 г.

Первый опубликованный (Действительный)

4 мая 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

4 мая 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

28 апреля 2026 г.

Последняя проверка

1 апреля 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • 260020
  • R01HL163960 (Грант/контракт NIH США)

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

ДА

Описание плана IPD

We will provide a data dictionary/dataset available upon reasonable request as needed.

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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