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NCT04528004 · ClinicalTrials.gov registry record · Early Phase 1
Mechanistic Studies of Nicotinamide Riboside in Human Heart Failure
A Early Phase 1 study of Heart Failure, Systolic and Metabolic Disturbance, sponsored by University of Washington.
- Active
- Registry status
- Early Phase 1
- Development phase
- 32
- Enrollment target
- 1
- Study location
NCT04528004 is a Early Phase 1 study of Heart Failure, Systolic and Metabolic Disturbance that is active but no longer recruiting, run by University of Washington. The registered enrollment target is 32 participants, below the 334-participant average among 13 other Heart Failure, Systolic trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04528004, a Early Phase 1 study of Heart Failure, Systolic and Metabolic Disturbance, is active but no longer recruiting, sponsored by University of Washington.
- ACTIVE NOT RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 32 participants
- Enrollment target
- 1
- Study location
Study Summary
Preliminary animal studies by ourselves and others suggest that the dietary supplement, nicotinamide riboside (NR), may improve cardiac function in heart failure (HF) by increasing cellular levels of its metabolite, nicotinamide adenine dinucleotide (NAD+, NADH). This Study will address a key gap in current knowledge by assessing the mechanisms through which raising blood and myocardial NAD+ levels in humans mediates changes in mitochondrial function, protein and epigenetic modifications, as well as inflammation. Human myocardium will be obtained after 4-14 days of oral NR supplementation from advanced heart failure patients undergoing elective left ventricular assist device (LVAD) implantation. Positive results would provide evidence to proceed with further studies of NR as a mitochondria-targeted metabolic therapy in heart failure.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Nicotinamide riboside
Study Locations (1)
Washington
- University of Washington - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2020-09-26 |
| Est. Completion | 2025-07-31 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04528004
The ClinicalTrials.gov registry entry for NCT04528004 describes a study currently listed as active not recruiting, categorized as Early Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 334-participant average among 13 other Heart Failure, Systolic trials with a reported enrollment target (90% lower). The listed sponsor is University of Washington, which has 1,048 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Heart Failure, Systolic appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04528004 reports 1 study location spanning 1 distinct geographic area - top geographies include Washington.
Frequently Asked Questions
What is clinical trial NCT04528004 about?
NCT04528004 is a clinical study titled "Mechanistic Studies of Nicotinamide Riboside in Human Heart Failure". Preliminary animal studies by ourselves and others suggest that the dietary supplement, nicotinamide riboside (NR), may improve cardiac function in heart failure (HF) by increasing cellular levels of its metabolite, nicotinamide adenine dinucleotide (NAD+, NADH). This Study will address a key gap in...
What is the current status of trial NCT04528004?
This trial is currently active not recruiting. It is a Early Phase 1 study. The enrollment target is 32 participants. The study started on 2020-09-26. Estimated completion is 2025-07-31.
What conditions does trial NCT04528004 study?
This clinical trial studies the following conditions: Heart Failure, Systolic, Metabolic Disturbance, Heart Failure NYHA Class IV.
What interventions are being tested in trial NCT04528004?
The interventions under investigation include: Placebo (OTHER), Nicotinamide riboside (DRUG).
Who is sponsoring clinical trial NCT04528004?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04528004 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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