Status:
COMPLETED
Nicotinamide Riboside in Systolic Heart Failure
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Heart Failure, Systolic
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Mitochondrial dysfunction has been implicated in heart failure (HF), and is associated with an imbalance in intracellular ratio of reduced nicotinamide-adenine dinucleotide (NADH) to oxidized nicotina...
Detailed Description
Aim 1: Determine the safety and tolerability of NR in patients with clinically stable, systolic heart failure (LVEF \<40%). To accomplish this Aim: A) a total of 30 participants with clinically stabl...
Eligibility Criteria
Inclusion
- Men and women aged 18 and older with systolic heart failure \[left ventricular ejection fraction (LVEF) by standard 2D echocardiography or radionuclide ventriculography of ≤40%\] deemed, in the clinical opinion of their treating cardiologist to be non-ischemic or ischemic in origin.
- Clinically stable (no cardiac procedures or hospitalizations for hospitalizations for cardiac causes, including HF, ischemia or arrhythmia) within the previous 3 months
- Ability to undergo study procedures, including scheduled visits, blood draws and six-minute walk test (6MWT)
- Willingness/ability to provide informed consent
Exclusion
- Heart failure with preserved ejection fraction (LVEF greater than 40%)
- Heart failure due, in the opinion of their treating cardiologist, 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, transient ischemic attack or arrhythmias within the previous 3 months
- Inability to perform Study visits or procedures (e.g., physical inability to perform 6MWT)
- Unwillingness/inability to provide informed consent
- ALT greater than 3 times the upper limit of normal, hepatic insufficiency or active liver disease
- Recent history of acute gout
- Chronic renal insufficiency with creatinine ≥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 long-term clinical trial
- History of intolerance to NR precursor compounds, including niacin or nicotinamide
Key Trial Info
Start Date :
May 19 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03423342
Start Date
May 19 2016
End Date
June 30 2019
Last Update
November 16 2022
Active Locations (1)
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1
University of Washington
Seattle, Washington, United States, 98195