Randomized Clinical Trial of β Nicotinamide Mononucleotide in Patients Undergoing CABG Surgery
Brigham and Women's Hospital
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.
Description
This is a phase 2a, randomized, double-blind, parallel-group, placebo-controlled clinical trial in adult patients undergoing elective coronary artery bypass grafting (CABG) surgery. A total of 90 patients will be randomized 1:1:1 to placebo or to one of two dosing regimens of NMN seven days prior to surgery as follows: Arm A: NMN 1,000 mg PO twice daily, administered for 7 days preoperatively, on the day of surgery, and for 4 days postoperatively Arm B: NMN 1,000 mg PO twice daily, administered for 2 days preoperatively, on the day of surgery, and for 4 days postoperatively Arm C: Placebo P…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 Crit…
Interventions
- DrugMIB-626
An orally-administered stable crystalline tablet formulation of NMN
- OtherPlacebo
matching placebo tablets
Location
- Brigham and Women's HospitalBoston, Massachusetts