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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 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 1,027-participant average among 5 other Heart Failure,Congestive trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.

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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.

Interventions

  • DIETARY_SUPPLEMENT Nicotinamide riboside

Study Locations (1)

Washington

  • University of Washington - Seattle

Trial Details

FieldValue
Enrollment Target 5 participants
Start Date 2018-09-26
Est. Completion 2018-11-26
Phase Early Phase 1

Sponsor

University of Washington

1,048 total trials

What the Registry Record Tells You About NCT03727646

The ClinicalTrials.gov registry entry for NCT03727646 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,027-participant average among 5 other Heart Failure,Congestive trials with a reported enrollment target (100% 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,Congestive appearing as the primary indexed condition, and to 1 intervention - of which Nicotinamide riboside is the first listed.

NCT03727646 reports 1 study location spanning 1 distinct geographic area - top geographies include 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.

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