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Nicotinamide Riboside for Heart Failure (NRII Trial)

Q: Are participants still able to join this research endeavor?

As indicated on clinicaltrials.gov, this medical research is actively searching for participants. It was initially uploaded to the website on September 26th 2020 and most recently revised on 30th of September 2022.

Q: Have any other trials been conducted using Nicotinamide riboside as a treatment?

Currently, 15 clinical trials for nicotinamide riboside are ongoing, with one being in the final Phase 3. Despite most of these studies taking place in Winston-Salem <a href="https://www.withpower.com/clinical-trials/north-carolina">North carolina</a>, 19 distinct medical centres are participating.

Q: How many individuals are being included in the research study?

Affirmative. The information on clinicaltrials.gov corroborates the fact that this study, which was originally posted on September 26th 2020 is currently recruiting patients. With 1 site in mind, 40 participants need to be recruited for the trial.

Phase < 1

Recruiting

Led By Kevin D O'Brien, MD

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

End-stage heart failure due to ischemic or non-ischemic cardiomyopathy

If implanted for destination therapy indication, must have New Your Heart Association (NYHA) Class IV Heart Failure AND left ventricular ejection fraction (LVEF) <25% OR maximum minute consumption of oxygen (VO2) <14 OR on requirement for continuous intravenous inotropes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 14 days

Awards & highlights

NRII Trial Summary

This trial will test whether the dietary supplement nicotinamide riboside (NR) can improve heart function in heart failure patients by increasing levels of the metabolite nicotinamide adenine dinucleotide (NAD+).

Who is the study for?

This trial is for adults over 18 with advanced heart failure who are scheduled for a left ventricular assist device (LVAD) implant. They must have severe symptoms or low heart function, and meet specific health criteria. People with other types of heart failure, serious liver or kidney disease, untreated thyroid issues, severe diabetes complications, high surgical risk factors, non-compliance to treatments, substance abuse problems or lack of caregiver support cannot join.Check my eligibility

What is being tested?

The study tests if nicotinamide riboside (NR), a dietary supplement thought to improve cardiac function by boosting NAD+ levels in the body can help patients with heart failure. Participants will take NR orally before getting an LVAD implantation to see if it improves mitochondrial function and reduces inflammation compared to a placebo.See study design

What are the potential side effects?

While not specified here, potential side effects may include those commonly associated with niacin-related compounds such as flushing of the skin, itching or rash; gastrointestinal discomfort like nausea or indigestion; and increased blood sugar levels.

NRII Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have advanced heart failure from a heart muscle problem.

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I have severe heart failure with very poor heart function or need constant heart medication.

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I am scheduled for, or will soon be scheduled for, a heart pump implant.

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I am older than 18 years.

NRII Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 14 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 14 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 14 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Between-group comparisons of whole blood NAD+ levels

Secondary outcome measures

Between-group comparisons of inflammatory markers in blood

Between-group comparisons of inflammatory markers in myocardium

Between-group comparisons of myocardial NAD(H) levels

+4 more

Other outcome measures

Correlations of myocardial NAD(H) levels with measures

Correlations of whole blood NAD+ levels with measures

NRII Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Nicotinamide ribosideExperimental Treatment1 Intervention

Participants randomized to Nicotinamide Riboside (NR) and scheduled to receive an LVAD will receive nicotinamide riboside (NR) capsules according to the following administration schedule: Dose Escalation Day 1: 250 mg (1 capsule) twice daily (total daily intake = 500 mg) Day 2: 500 mg (2 capsules) twice daily (total daily intake = 1000 mg) Day 3: 1000 mg (4 capsules) twice daily (total daily intake = 2000 mg) Dose Maintenance Day 4: 1000 mg (4 capsules) twice daily Day 5-14 as applicable thru Day Before Surgery: 1000 mg (4 capsules) twice daily Washout Day of LVAD Surgery and/or Day 15: None

Group II: PlaceboPlacebo Group1 Intervention

Participants randomized to Placebo and scheduled to receive an LVAD will receive Placebo capsules according to the following administration schedule: Dose Escalation Day 1: 250 mg (1 capsule) twice daily (total daily intake = 500 mg) Day 2: 500 mg (2 capsules) twice daily (total daily intake = 1000 mg) Day 3: 1000 mg (4 capsules) twice daily (total daily intake = 2000 mg) Dose Maintenance Day 4: 1000 mg (4 capsules) twice daily Day 5-14 as applicable thru Day Before Surgery: 1000 mg (4 capsules) twice daily Washout Day of LVAD Surgery and/or Day 15: None

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nicotinamide riboside

Not yet FDA approved

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,834 Previous Clinical Trials

47,310,595 Total Patients Enrolled

206 Trials studying Heart Failure

677,408 Patients Enrolled for Heart Failure

University of WashingtonLead Sponsor

1,738 Previous Clinical Trials

1,844,311 Total Patients Enrolled

17 Trials studying Heart Failure

19,542 Patients Enrolled for Heart Failure

Kevin D O'Brien, MDPrincipal InvestigatorUniversity of Washington

2 Previous Clinical Trials

38 Total Patients Enrolled

1 Trials studying Heart Failure

30 Patients Enrolled for Heart Failure

Media Library

Nicotinamide Riboside (Vitamin) Clinical Trial Eligibility Overview. Trial Name: NCT04528004 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants still able to join this research endeavor?

"As indicated on clinicaltrials.gov, this medical research is actively searching for participants. It was initially uploaded to the website on September 26th 2020 and most recently revised on 30th of September 2022."

Answered by AI

Have any other trials been conducted using Nicotinamide riboside as a treatment?

"Currently, 15 clinical trials for nicotinamide riboside are ongoing, with one being in the final Phase 3. Despite most of these studies taking place in Winston-Salem North carolina, 19 distinct medical centres are participating."

Answered by AI

How many individuals are being included in the research study?

"Affirmative. The information on clinicaltrials.gov corroborates the fact that this study, which was originally posted on September 26th 2020 is currently recruiting patients. With 1 site in mind, 40 participants need to be recruited for the trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Mechanistic Studies of Nicotinamide Riboside in Human Heart Failure

Kevin O'Brien 2020. "Mechanistic Studies of Nicotinamide Riboside in Human Heart Failure". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04528004.

All > Heart Failure With Preserved Ejection Fraction