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NCT03727646 · ClinicalTrials.gov registry record · Early Phase 1
Nicotinamide Riboside in LVAD Recipients
A Early Phase 1 study of Heart Failure, Congestive and Mitochondrial Alteration, sponsored by University of Washington.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 5
- Enrollment target
- 1
- Study location
NCT03727646: Completed Early Phase 1 study of Heart Failure, Congestive and Mitochondrial Alteration, sponsored by University of Washington.
NCT03727646 is a Early Phase 1 study of Heart Failure, Congestive and Mitochondrial Alteration that has completed, run by University of Washington. The registered enrollment target is 5 participants, below the 675-participant average among 39 other Heart Failure, Congestive trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03727646, a Early Phase 1 study of Heart Failure, Congestive and Mitochondrial Alteration, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 5 participants
- Enrollment target
- 1
- Study location
Study Summary
While preliminary data show that oral nicotinamide riboside (NR) supplementation increases myocardial levels of oxidized nicotine-adenine dinucleotide (NAD+) levels in mice, there has been no direct evidence that suggests oral NR increases NAD+ levels or improves mitochondrial function in human hearts. This Pilot Study is designed to obtain feasibility data for a planned, larger study testing the hypothesis that oral NR supplementation will increase myocardial NAD+ levels and improve cardiomyocyte mitochondrial function in participants with advanced heart failure planned for elective left ventricular assist device (LVAD) implantation. To demonstrate safety and feasibility of NR in this patient population, the investigators propose to enroll 5 participants planned for LVAD implantation in a Pilot Study of NR in which participants will receive NR, up-titrated over 3 days to a final NR dose of 1000mg twice daily. Blood and myocardial tissue analyses collected previously from age- and gender-matched LVAD recipients will serve as controls.
Primary Outcome
Participants experiencing adverse events during the time they are on the study drug. Regarding time frame: Day 1 is the first day that the study subjects start taking the study drug (NR). The participants stop taking the study drug on the day before his/her LVAD surgery (between Days 6 and 14).
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Nicotinamide riboside
Study Locations (1)
Washington
- University of Washington - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2018-09-26 |
| Est. Completion | 2018-11-26 |
| Phase | Early Phase 1 |
What the finished NCT03727646 record still lists
NCT03727646 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 675-participant average among 39 other Heart Failure, Congestive trials with a reported enrollment target (99% lower).
The record links to 3 conditions, with Heart Failure, Congestive appearing as the primary indexed condition, and to 1 intervention - of which Nicotinamide riboside is the first listed.
NCT03727646 reports a single indexed study location in Washington.
Frequently Asked Questions
What is clinical trial NCT03727646 about?
NCT03727646 is a clinical study titled "Nicotinamide Riboside in LVAD Recipients". While preliminary data show that oral nicotinamide riboside (NR) supplementation increases myocardial levels of oxidized nicotine-adenine dinucleotide (NAD+) levels in mice, there has been no direct evidence that suggests oral NR increases NAD+ levels or improves mitochondrial function in human hear...
What is the current status of trial NCT03727646?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 5 participants. The study started on 2018-09-26. Estimated completion is 2018-11-26.
What conditions does trial NCT03727646 study?
This clinical trial studies the following conditions: Heart Failure, Congestive, Mitochondrial Alteration, Heart Failure New York Heart Association Class IV.
What interventions are being tested in trial NCT03727646?
The interventions under investigation include: Nicotinamide riboside (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT03727646?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03727646 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Heart Failure, Congestive
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03727646's enrollment target sits among peer trials
5 40th of 39 the lowest of 39 other Heart Failure, Congestive trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heart Failure, Congestive 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.
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