NCT07013591 Nicotinamide Mononucleotide in Patients Undergoing CABG Surgery
| NCT ID | NCT07013591 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Brigham and Women's Hospital |
| Condition | Coronary Artery Bypass Graft |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2026-06-10 |
| Primary Completion | 2028-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 90 participants in total. It began in 2026-06-10 with a primary completion date of 2028-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The investigators will perform a phase 2a, randomized, double-blind, placebo-controlled clinical trial in adult patients undergoing elective coronary artery bypass grafting (CABG) surgery to investigate the effects of oral nicotinamide mononucleotide (NMN) administration on myocardial NAD+ concentrations and on postoperative markers of myocardial and kidney injury.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥18 years 2. Scheduled to undergo elective isolated CABG 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 and urine albumin-to-creatinine ratio \>30 mg/g creatinine 5. Peripheral arterial disease 6. Anemia, defined as hemoglobin \<10 g/dl 7. 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 gastric bypass or malabsorption 3. Active alcohol 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
Contact & Investigator
Shalender Bhasin, MB, BS
PRINCIPAL INVESTIGATOR
Brigham and Women's Hosptial
Frequently Asked Questions
Who can join the NCT07013591 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coronary Artery Bypass Graft. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07013591 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07013591 currently recruiting?
Yes, NCT07013591 is actively recruiting participants. Contact the research team at sbhasin@bwh.harvard.edu for enrollment information.
Where is the NCT07013591 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT07013591 clinical trial?
NCT07013591 is sponsored by Brigham and Women's Hospital. The principal investigator is Shalender Bhasin, MB, BS at Brigham and Women's Hosptial. The trial plans to enroll 90 participants.