Heart Failure,Congestive Clinical Trial
— PilotNR-LVADOfficial title:
Pilot Study of Preoperative Nicotinamide Riboside (Vitamin B3) Supplementation in Patients Undergoing Elective Left Ventricular Assist Device (LVAD) Implantation
Verified date | August 2020 |
Source | University of Washington |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
While preliminary data show that oral nicotinamide riboside (NR) supplementation increases myocardial levels of oxidized nicotine-adenine dinucleotide (NAD+) levels in mice, there has been no direct evidence that suggests oral NR increases NAD+ levels or improves mitochondrial function in human hearts. This Pilot Study is designed to obtain feasibility data for a planned, larger study testing the hypothesis that oral NR supplementation will increase myocardial NAD+ levels and improve cardiomyocyte mitochondrial function in participants with advanced heart failure planned for elective left ventricular assist device (LVAD) implantation. To demonstrate safety and feasibility of NR in this patient population, the investigators propose to enroll 5 participants planned for LVAD implantation in a Pilot Study of NR in which participants will receive NR, up-titrated over 3 days to a final NR dose of 1000mg twice daily. Blood and myocardial tissue analyses collected previously from age- and gender-matched LVAD recipients will serve as controls.
Status | Completed |
Enrollment | 5 |
Est. completion date | November 26, 2018 |
Est. primary completion date | November 26, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Diagnosis of advanced heart failure. - Planned elective LVAD implantation surgery with patient agreements for candidacy in place as required by UWMC. - Hospital inpatient at time of enrollment. - Ability to undergo Study procedures. - Willingness/ability to provide informed consent. Exclusion Criteria: - Current smoking - Receiving certain concurrent supplements (to be determined at discretion of the PI). Note that UWMC Nutrition Care standards call for a general multivitamin (1 tab PO daily) as part of the advanced heart failure therapy (AHFT) work-up. - Known allergies to niacin or nicotinamide. - Hepatic, renal, endocrine, or neurological disease that disqualify them from consideration for LVAD implantation. - Inability to perform Study visits or procedures. - Unwillingness/inability to provide informed consent. - Women who are currently pregnant or who wish to become pregnant over the course of the study follow-up are not allowed to join this study. This exclusion is built into the LVAD candidate selection process. |
Country | Name | City | State |
---|---|---|---|
United States | University of Washington | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
University of Washington | American Heart Association |
United States,
Zhou B, Wang DD, Qiu Y, Airhart S, Liu Y, Stempien-Otero A, O'Brien KD, Tian R. Boosting NAD Level Suppresses Inflammatory Activation of PBMC in Heart Failure. J Clin Invest. 2020 Aug 13. pii: 138538. doi: 10.1172/JCI138538. [Epub ahead of print] — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) | Adverse Events | Up to 14 days | |
Secondary | Effect of NR on whole blood NAD+ levels | Change in whole blood NAD+ levels from Baseline to Day of Surgery in NR-treated participants | Duration of NR treatment | |
Secondary | Effect of NR on mitochondrial respiration (Seahorse assay) in isolated peripheral blood mononuclear cells (PBMCs) | Change in mitochondrial respiration from Baseline to Day of Surgery in NR-treated participants | Up to 14 days | |
Secondary | Between-group comparison of whole blood NAD+ levels | Comparison of whole blood NAD+ levels on the Day of LVAD Surgery in NR-treated vs. historical control patients | Up to 14 days | |
Secondary | Between-group comparison of mitochondrial respiration in PBMCs | Comparison of mitochondrial respiration in PBMCs on the Day of LVAD Surgery in NR-treated vs. historical control patients | Up to 14 days |
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