๐ฌIn plain words
What the trial is, and whether it could suit you
The investigators will perform a phase 2a, randomized, double-blind, placebo-controlled clinical trial in adult patients undergoing elective cardiac surgery to investigate the effects of oral nicotinamide mononucleotide (NMN) administration on myocardial NAD+ concentrations and on postoperative markers of myocardial and kidney injury.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
1. Age โฅ18 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 โฅ1 of the following:
1. Age โฅ65 years
2. eGFR \<45 ml/min/1.73m2
3. Documented history of congestive heart failure or left ventricular ejection fraction (LVEF) โค40% 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