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Vitamin

Nicotinamide Riboside for Heart Failure (NRII 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
Must not have
End-stage heart failure due to causes other than ischemic or non-ischemic cardiomyopathy (e.g., valvular, hypertrophic or infiltrative cardiomyopathies)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 14 days
Awards & highlights

Summary

This trial tests whether a vitamin B3 supplement called nicotinamide riboside can help patients with severe heart failure by improving their cell energy production and reducing inflammation. The study focuses on patients undergoing heart surgery to implant a device that helps their heart pump blood.

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.
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.
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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My heart failure is not caused by common heart muscle issues.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Between-group comparisons of whole blood NAD+ levels
Secondary study objectives
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 study objectives
Correlations of myocardial NAD(H) levels with measures
Correlations of whole blood NAD+ levels with measures

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for heart failure (HF) often target improving myocardial function and reducing inflammation, which are crucial for managing the disease. Nicotinamide Riboside (NR) is being studied for its potential to increase NAD+ levels, thereby enhancing mitochondrial function and reducing inflammation. This is important because improved mitochondrial function can enhance energy production in heart cells, which is often compromised in HF. Additionally, reducing inflammation can prevent further cardiac damage. Other treatments, such as beta-blockers, work by reducing the heart's workload and oxygen demand, while ACE inhibitors and ARBs help relax blood vessels and reduce blood pressure, improving blood flow and reducing strain on the heart. Diuretics help remove excess fluid, reducing symptoms like swelling and shortness of breath. These mechanisms collectively aim to improve heart function, reduce symptoms, and enhance the quality of life for HF patients.

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,889 Previous Clinical Trials
47,834,167 Total Patients Enrolled
208 Trials studying Heart Failure
677,669 Patients Enrolled for Heart Failure
University of WashingtonLead Sponsor
1,791 Previous Clinical Trials
1,905,466 Total Patients Enrolled
18 Trials studying Heart Failure
19,742 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
~4 spots leftby Mar 2025
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