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NCT03565328 · ClinicalTrials.gov registry record · Phase 2
The Effect of Nicotinamide Riboside on Skeletal Muscle Function in Heart Failure Subjects
A Phase 2 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Terminated
- Registry status
- Phase 2
- Development phase
- 2
- Enrollment target
NCT03565328: Clinical Trial Phase 2 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT03565328 is a Phase 2 study that was terminated before completion, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 2 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03565328, a Phase 2 study, was terminated before completion, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 2 participants
- Enrollment target
Study Summary
Background: People are living longer and are more likely to survive a heart attack if they have one. Longer life expectancy is good but it also means more people get chronic heart failure over time. This is a condition in which the heart doesn't pump blood as well as it should. Treatment of chronic heart failure has not improved much in a few decades. Researchers want to see if giving a dietary supplement to people with heart failure can help their heart function. The supplement is nicotinamide riboside (NR). Objective: To study how NR affects skeletal muscle function in people with heart failure. Eligibility: Adults ages 18-70 with clinically stable systolic heart failure Design: Participants will be screened with a medical history and physical exam. They will answer demographic questions and review their current medical treatments. They will have blood and urine tests. They will have an echocardiogram. This uses sound waves to test heart function. Participants will have 8 study visits over 16 weeks. At these visits, they will have some of the following: Repeat of screening tests Skin sample taken Skeletal muscle exercise Nuclear magnetic resonance (NMR) spectroscopy. Muscles will be measured while participants do foot exercises. Cardiopulmonary exercise testing. Participants may ride a stationary bike or walk on a treadmill. A facemask will analyze their breath. Heart and blood pressure measurements will be taken. Participants will take the supplement in pill form each day for 12 weeks. Pill bottles will be checked at study visits. Participants should not significantly change their activity levels during the study.
Primary Outcome
Number of participants who had enhancement mitochondrial function in skeletal muscle Nuclear magnetic resonance (NMR) spectroscopy will be performed at baseline, at the end of the 12-week Nicotinamide Riboside (NR) supplementation period and repeated 4 weeks post-NR washout.
Interventions
- DIETARY_SUPPLEMENT Nicotinamide Riboside
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2018-09-27 |
| Est. Completion | 2019-11-18 |
| Phase | Phase 2 |
Why NCT03565328 stopped before completion
NCT03565328 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Nicotinamide Riboside is the first listed.
NCT03565328 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03565328 about?
NCT03565328 is a clinical study titled "The Effect of Nicotinamide Riboside on Skeletal Muscle Function in Heart Failure Subjects". Background: People are living longer and are more likely to survive a heart attack if they have one. Longer life expectancy is good but it also means more people get chronic heart failure over time. This is a condition in which the heart doesn't pump blood as well as it should. Treatment of chronic...
What is the current status of trial NCT03565328?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2018-09-27. Estimated completion is 2019-11-18.
What interventions are being tested in trial NCT03565328?
The interventions under investigation include: Nicotinamide Riboside (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT03565328?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03565328's enrollment target sits among peer trials
2 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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