What side effects are associated with this type of intervention?

Common treatments for heart failure that aim to improve mitochondrial function and reduce inflammation include medications like beta-blockers, ACE inhibitors, and ARBs. Beta-blockers can cause side effects such as fatigue, cold hands and feet, weight gain, and depression. ACE inhibitors may lead to a persistent dry cough, elevated blood potassium levels, low blood pressure, and kidney dysfunction. ARBs have similar side effects to ACE inhibitors but are less likely to cause a cough. Diuretics, another common treatment, can cause electrolyte imbalances, dehydration, and kidney issues. While Nicotinamide Riboside is still under investigation, its goal of enhancing mitochondrial function and reducing inflammation aligns with these treatments, though its specific side effects are not yet fully understood.

What prior FDA approvals exist?

FDA-approved treatments for heart failure have traditionally included medications such as ACE inhibitors, beta-blockers, diuretics, and mineralocorticoid receptor antagonists. These drugs primarily focus on reducing symptoms, improving heart function, and preventing hospitalizations. While Nicotinamide Riboside, which aims to increase NAD+ levels to enhance mitochondrial function and reduce inflammation, is still under investigation, other metabolic therapies like Coenzyme Q10 have been explored but have not shown significant benefits in clinical trials. Thus, current FDA-approved treatments do not yet include therapies specifically targeting NAD+ levels.

What other types of research exist?

Promising alternatives to Nicotinamide Riboside for heart failure patients include: 1) Tafamidis, which has shown to reduce mortality and cardiovascular-related hospitalizations in patients with amyloid cardiomyopathy by stabilizing transthyretin tetramers. 2) Soluble guanylate cyclase stimulators like vericiguat, which have shown potential benefits in improving quality of life and reducing NT-proBNP levels in heart failure patients. 3) Sodium-glucose cotransporter 2 (SGLT2) inhibitors such as empagliflozin and canagliflozin, which have demonstrated cardiovascular benefits in patients with type 2 diabetes and heart failure.

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Vitamin

Nicotinamide Riboside for Heart Failure (NRII Trial)

Q: What is the mechanism of action of this treatment?

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.

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

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

Select...

I have advanced heart failure from a heart muscle problem.

Select...

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:

Select...

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

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

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

0 / 5Eligibility criteria met

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.