Nicotinamide Riboside for Heart Failure

(NRII Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Kevin D O'Brien, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: University of Washington

Disqualifiers: Cirrhosis, Severe renal disease, Untreated thyroid, others

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it mentions that non-compliance with current treatments is an exclusion criterion, suggesting that you may need to continue your existing medications.

How is the drug Nicotinamide Riboside unique in treating heart failure?

Nicotinamide Riboside is unique because it boosts NAD+ levels in the body, which is important for energy production and cellular health, potentially offering a novel approach to treating heart failure by improving mitochondrial function and reducing inflammation. ^{1 2 3 4 5}

Research Team

Kevin D O'Brien, MD

Principal Investigator

University of Washington

Eligibility Criteria

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.

Inclusion Criteria

I have advanced heart failure from a heart muscle problem.

Meet clinical and socioeconomic screening criteria for elective LVAD implantation by the University of Washington Mechanical Circulatory Support Program

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

Exclusion Criteria

You have liver disease, severe kidney problems, untreated thyroid issues, severe complications from diabetes, or other health issues that make it too risky for you to have a heart pump implanted. You also must follow your doctor's orders and not abuse drugs or have problems getting to your medical appointments.

My heart failure is not caused by common heart muscle issues.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive nicotinamide riboside (NR) or placebo with dose escalation over 3 days, followed by maintenance dosing until the day before LVAD surgery

14 days

Daily dosing with final labs on the day of surgery

Follow-up

Participants are monitored for safety and effectiveness after treatment, including analysis of myocardial and blood samples

4 weeks

Treatment Details

Interventions

• Nicotinamide Riboside (Vitamin)

Trial Overview 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.

Participant Groups

Group I: Nicotinamide riboside Experimental Treatment 1 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: Placebo Placebo Group 1 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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Washington Seattle, WA

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1858

Patients Recruited

2,023,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3987

Patients Recruited

47,860,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nicotinamide Riboside Supplementation Restores Myocardial Nicotinamide Adenine Dinucleotide Levels, Improves Survival, and Promotes Protective Environment Post Myocardial Infarction. Tannous, C., Ghali, R., Karoui, A., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Tolerability of Nicotinamide Riboside in Heart Failure With Reduced Ejection Fraction. Wang, DD., Airhart, SE., Zhou, B., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nicotinamide Riboside-The Current State of Research and Therapeutic Uses. Mehmel, M., Jovanović, N., Spitz, U.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emerging Role of Nicotinamide Riboside in Health and Diseases. Sharma, C., Donu, D., Cen, Y.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A reduced form of nicotinamide riboside defines a new path for NAD+ biosynthesis and acts as an orally bioavailable NAD+ precursor. Giroud-Gerbetant, J., Joffraud, M., Giner, MP., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Nicotinamide Riboside Supplementation Restores Myocardial Nicotinamide Adenine Dinucleotide Levels, Improves Survival, and Promotes Protective Environment Post Myocardial Infarction. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Safety and Tolerability of Nicotinamide Riboside in Heart Failure With Reduced Ejection Fraction. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Nicotinamide Riboside-The Current State of Research and Therapeutic Uses. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Emerging Role of Nicotinamide Riboside in Health and Diseases. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

A reduced form of nicotinamide riboside defines a new path for NAD+ biosynthesis and acts as an orally bioavailable NAD+ precursor. [2021]