Nicotinamide Mononucleotide for patients undergoing cardiac surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 2a, randomized, double-blind, placebo-controlled trial in adults undergoing elective cardiac surgery. Participants are assigned to two NMN dosing regimens or placebo, starting up to 7 days before surgery and continuing for several days afterward. The trial will evaluate whether NMN increases myocardial NAD+ levels and reduces markers of heart and kidney injury after surgery. The study uses a parallel-group design with three arms and aims to enroll 90 participants. Primary outcomes focus on biochemical and clinical indicators of cardiac and renal injury in the perioperative period.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥18 years
2. Scheduled to undergo elective isolated CABG surgery and/or valve surgery with cardiopulmonary bypass (CPB)
3. At increased risk of postoperative complications based on ≥1 of the following:

   1. Age ≥65 years
   2. eGFR \<45 ml/min/1.73m2
   3. Documented history of congestive heart failure or left ventricular ejection fraction (LVEF) ≤40% within 6 months before surgery
   4. Diabetes mellitus
   5. Proteinuria defined as urine albumin-to-creatinine ratio \>30 mg/g creatinine, urine protein-to-creatinine ratio \>0.05g/g creatinine, or 2+ or greater proteinuria on a urinalysis
   6. Peripheral arterial disease
   7. Anemia, defined as hemoglobin \<10 g/dl
   8. Prior cardiac surgery

Exclusion Criteria:

1. Any of the following laboratory abnormalities at the time of screening:

   1. ALT \>3-fold the upper limit of normal
   2. eGFR \<30 ml/min/1.73m2 or ESKD on dialysis
   3. Hemoglobin \<8 g/dl
2. History of malabsorption
3. Active alcohol abuse or illicit substance use in the prior 6 months
4. Participation in an investigational trial to evaluate pharmaceuticals or biologics within the past 3 months or 5 half-lives, whichever is shorter
5. Pregnant or breast-feeding
6. Unwillingness to use contraception while taking study drug and for 8 weeks after the last dose for women of reproductive age or non-sterilized male participants who are sexually active with a female partner of childbearing potential
7. Current use of niacin \>100 mg/day or NMN, nicotinamide, or nicotinamide riboside at any dose
8. Conflict with other research studies
9. Any condition which, in the judgement of the investigator, might increase the risk to the participant

Where it's running

• Brigham and Women's Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Shalender Bhasin, MB, BS — Brigham and Women's Hosptial
• Study coordinator: Shalender Bhasin, MB,BS
• Email: sbhasin@bwh.harvard.edu
• Phone: 617-525-9150

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.