Nicotinamide Mononucleotide for Coronary Artery Bypass Surgery

Overseen By David E Leaf, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Brigham and Women's Hospital

Must not be taking: Niacin, NMN, Nicotinamide

Disqualifiers: Gastric bypass, Alcohol use, Pregnancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called nicotinamide mononucleotide (NMN) to determine its effectiveness in aiding recovery after coronary artery bypass grafting (CABG) surgery. Researchers aim to assess whether NMN can enhance heart and kidney health during recovery. The trial includes two groups taking NMN at different times and doses, and one group taking a placebo (a pill with no active ingredient). Eligible participants are those scheduled for elective CABG surgery and have certain health conditions, such as diabetes, heart failure, or a history of heart surgeries. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant medical advancements.

Do I need to stop taking my current medications for this trial?

The trial requires that you stop taking niacin over 100 mg/day or any form of nicotinamide, including NMN and nicotinamide riboside. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

Is there any evidence suggesting that nicotinamide mononucleotide is likely to be safe for humans?

Research has shown that nicotinamide mononucleotide (NMN) is generally safe for people. A safety board regularly reviewed a study and found that taking NMN orally was safe for individuals with heart disease, with no major safety issues reported. Another study on a similar compound, nicotinamide riboside, found it was safe and well-tolerated even at higher doses over 12 weeks. These findings suggest NMN is likely safe for short-term use, as planned in this trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about Nicotinamide Mononucleotide (NMN) for coronary artery bypass surgery because it offers a novel approach compared to traditional treatments. While standard care often involves managing symptoms and improving heart function through medications like beta-blockers and ACE inhibitors, NMN focuses on boosting cellular energy and reducing oxidative stress by enhancing NAD+ levels in the body. This unique mechanism could potentially improve recovery times and surgical outcomes. Moreover, the treatment is administered orally, which might be more convenient and less invasive than other options.

What evidence suggests that nicotinamide mononucleotide might be an effective treatment for coronary artery bypass surgery?

Research has shown that nicotinamide mononucleotide (NMN) might help reduce heart and kidney damage after heart surgery. One study found that NMN lowered creatinine levels, indicating reduced kidney stress, in patients undergoing heart surgery. This suggests NMN could protect the kidneys during these procedures. NMN is believed to work by increasing NAD+ levels in cells, which is crucial for cell health and energy. In animal studies, NMN improved heart function and reduced heart damage. This trial will evaluate NMN's potential benefits with different dosing regimens: some participants will receive NMN for 7 days preoperatively, on the day of surgery, and for 4 days postoperatively, while others will receive it for 2 days preoperatively, on the day of surgery, and for 4 days postoperatively. These findings offer hope that NMN could aid recovery after coronary artery bypass surgery. ^{2 4 6 7 8}

Who Is on the Research Team?

Shalender Bhasin, MB, BS

Principal Investigator

Brigham and Women's Hosptial

Are You a Good Fit for This Trial?

Adults over 18 scheduled for elective coronary artery bypass grafting (CABG) surgery with cardiopulmonary bypass can join. Especially those over 65, with reduced kidney function or heart efficiency, diabetes with kidney stress, peripheral arterial disease, anemia, or previous cardiac surgery are eligible.

Inclusion Criteria

I have a history of heart failure or my heart pumps less effectively.

I have diabetes and a high level of protein in my urine.

I am 18 years old or older.

Exclusion Criteria

Pregnant or breast-feeding

Any condition which, in the judgement of the investigator, might increase the risk to the participant

I am currently taking more than 100 mg/day of niacin or any dose of NMN, nicotinamide, or nicotinamide riboside.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Treatment

Participants receive NMN or placebo for 7 days preoperatively

7 days

Daily administration

Surgery and Immediate Postoperative Treatment

Participants undergo CABG surgery and continue NMN or placebo for 4 days postoperatively

5 days

In-hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of myocardial and kidney injury parameters

90 days

Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• Nicotinamide Mononucleotide

Trial Overview This phase 2a trial tests if NMN (MIB-626), a dietary supplement thought to boost cell health, affects heart and kidney injury markers after CABG surgery compared to a placebo. Participants won't know which they're getting.

How Is the Trial Designed?

Group I: NMN administered for 2 days preoperatively, on the day of surgery, and for 4 days postoperatively Experimental Treatment 1 Intervention

NMN (MIB-626) 1,000 mg PO twice daily, administered for 2 days preoperatively, on the day of surgery, and for 4 days postoperatively

Group II: NMN (MIB-626) for 7 days preoperatively, on day of surgery, and for 4 days postoperatively Experimental Treatment 1 Intervention

NMN (MIB-626) 1000 mg PO daily, for 7 days preoperatively, on day of surgery, and for 4 days postoperatively

Group III: Placebo Placebo Group 1 Intervention

Placebo administered for 7 days preoperatively, on the day of surgery, and for 4 days postoperatively

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07013591

Nicotinamide Mmononucleotide in Patients Undergoing ... The investigators will perform a phase 2a, randomized, double-blind, placebo-controlled clinical trial in adult patients undergoing elective coronary artery ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12312518/

Oral MIB‐626 (β Nicotinamide Mononucleotide) Safely ... In a pilot randomized clinical trial, NAM was reported to attenuate creatinine elevation in patients undergoing cardiac surgery; the trial did not report the ...

3. withpower.com withpower.com/trial/phase-2-coronary-artery-bypass-grafting-cabg-9-2025-73fca

Nicotinamide Mononucleotide for Coronary Artery Bypass ... Trial Overview This phase 2a trial tests if NMN (MIB-626), a dietary supplement thought to boost cell health, affects heart and kidney injury markers after CABG ...

4. trial.medpath.com trial.medpath.com/clinical-trial/40cbaddaf3429ad3/nct07013591-nicotinamide-mononucleotide-cabg-patients

Nicotinamide Mmononucleotide in Patients Undergoing CABG ... The investigators will perform a phase 2a, randomized, double-blind, placebo-controlled clinical trial in adult patients undergoing elective coronary artery ...

5. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.121.056589

NAD+ Metabolism in Cardiac Health, Aging, and Disease NMN also improves isoproterenol-induced cardiac hypertrophy, fibrosis, and dysfunction in vivo. Similarly, nicotinamide protects from cardiac ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07013591

Nicotinamide Mmononucleotide in Patients Undergoing ... There are two major study aims: Aim 1: Test the effect of oral NMN administration on myocardial NAD+ concentration. Aim 2: Test the effect of oral NMN ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2452302X22002327

Safety and Tolerability of Nicotinamide Riboside in Heart ... In in this study, NR at 2 g/d over 12 weeks was safe, well tolerated, and significantly increased whole blood NAD+ levels in ambulatory stage C HFrEF patients.

8. mdpi.com mdpi.com/1422-0067/25/17/9526

Research Process in Cardiovascular Diseases The results of the current research indicate that NMN supplementation exhibits potential anti-aging and cardiovascular protective properties.