The Effect of Nicotinamide Riboside on Skeletal Muscle Function in Heart Failure Subjects

Stopped early · Phase 2

Conditions studied: Heart Failure

In brief

Background: People are living longer and are more likely to survive a heart attack if they have one. Longer life expectancy is good but it also means more people get chronic heart failure over time. This is a condition in which the heart doesn't pump blood as well as it should. Treatment of chronic heart failure has not improved much in a few decades. Researchers want to see if giving a dietary supplement to people with heart failure can help their heart function. The supplement is nicotinamide riboside (NR). Objective: To study how NR affects skeletal muscle function in people with heart failure. Eligibility: Adults ages 18-70 with clinically stable systolic heart failure Design: Participants will be screened with a medical history and physical exam. They will answer demographic questions and review their current medical treatments. They will have blood and urine tests. They will have an echocardiogram. This uses sound waves to test heart function. Participants will have 8 study visits over 16 weeks. At these visits, they will have some of the following: Repeat of screening tests Skin sample taken Skeletal muscle exercise Nuclear magnetic resonance (NMR) spectroscopy. Muscles will be measured while participants do foot exercises. Cardiopulmonary exercise testing. Participants may ride a stationary bike or walk on a treadmill. A facemask will analyze their breath. Heart and blood pressure measurements will be taken. Participants will take the supplement in pill form each day for 12 weeks. Pill bottles will be checked at study visits. Participants should not significantly change their activity levels during the study.

Key facts

Study ID

NCT03565328

Run by

National Heart, Lung, and Blood Institute (NHLBI)

People needed

2

Starts

2018-09-27

Expected to finish

2019-11-18

Last updated by the study team

2020-10-28

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Heart failure with preserved ejection fraction (LVEF greater than 45%)
• Change in heart failure medications due to deterioration of function with the exception of up- or down-titration of diuretic dose up to 100% of baseline dose.
• Heart failure due to etiologies other than non-ischemic or ischemic. Examples of exclusionary heart failure etiologies include primary valvular disease, or infiltrative or inflammatory cardiomyopathies.
• Cardiac surgery, percutaneous coronary intervention (PCI) or cardiac device implantation within the previous 3 months
• Hospitalizations for cardiovascular causes, including heart failure, chest pain, stroke/TIA or arrhythmias within the previous 3 months
• Inability to perform Study visits or procedures (e.g., physical inability to perform exercise testing)
• Unwillingness/inability to provide informed consent
• ALT greater than x3 upper limit of normal, hepatic insufficiency or active liver disease
• Recent history of acute gout
• Chronic renal insufficiency with creatinine greater than 2.5mg/dl
• Pregnant (or likely to become pregnant) women
• Significant co-morbidity likely to cause death in the 6 month follow-up period
• Significant active history of substance abuse within the previous 5 years
• Current participation in another drug study
• History of intolerance to NR precursor compounds, including niacin or nicotinamide
• MRI incompatible hardware including pacemakers or ICD s
• Study adherence concerns
• Individuals with diabetes type 1 and 2 who use insulin
• Women of child-bearing potential unwilling to use contraception or unwilling to practice abstinence
• Breastfeeding women unwilling to stop breastfeeding

Where it is running

• Walter Reed National Military Medical Center — Bethesda, Maryland, United States
• National Institutes of Health Clinical Center — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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