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Recruiting NCT07013591

Nicotinamide Mononucleotide in Patients Undergoing CABG Surgery

Phase II Interventional Coronary Artery Bypass Graft

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MIB-626, Placebo.
Who it may be relevant to
Registry conditions: Coronary Artery Bypass Graft. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Randomized Clinical Trial of β Nicotinamide Mononucleotide in Patients Undergoing CABG Surgery

Overview

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.

Detailed 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 PO twice daily, administered for 7 days preoperatively, on the day of surgery, and for 4 days postoperatively

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 administration on postoperative myocardial and kidney injury parameters.

Interventions

  • Drug MIB-626
    An orally-administered stable crystalline tablet formulation of NMN
  • Other Placebo
    matching placebo tablets

Primary outcome measures

  • NAD+ concentration in the myocardial tissue [Time frame: Intraoperatively (single time point)]
Secondary outcome measures (12)
  • Intracellular levels of NAD+ and related metabolites [Time frame: Intraoperatively (single time point)]
  • Circulating levels of NAD+ and related metabolites [Time frame: Baseline to day 90]
  • Markers of cardiac injury/dysfunction [Time frame: Preoperatively, on ICU arrival, and on postoperative days 1-4]
  • Acute kidney injury (AKI) [Time frame: 7 days post-operatively]
  • Serum creatinine (SCr) [Time frame: Immediately pre-operative to 7 days post-operative]
  • Cystatin C [Time frame: Preoperatively, on ICU arrival, and on postoperative days 1-4]
  • Neutrophil gelatinase-associated lipocalin (NGAL) [Time frame: Preoperatively, on ICU arrival, and on postoperative days 1-4]
  • Kidney Injury Molecule-1 (KIM-1) [Time frame: Preoperatively, on ICU arrival, and on postoperative days 1-4]
  • NMN level [Time frame: Preoperatively, on ICU arrival, and on postoperative days 1-4]
  • 2PY Level [Time frame: Preoperatively, on ICU arrival, and on postoperative days 1-4]
  • N-Methylnicotinamide level [Time frame: Preoperatively, on ICU arrival, and on postoperative days 1-4]
  • nicotinamide level [Time frame: Preoperatively, on ICU arrival, and on postoperative days 1-4]

Eligibility criteria

Inclusion criteria

  • Age ≥18 years
  • Scheduled to undergo elective isolated CABG surgery with cardiopulmonary bypass (CPB)
  • At increased risk of postoperative complications based on ≥1 of the following:
  • Age ≥65 years
  • eGFR <45 ml/min/1.73m2
  • Documented history of congestive heart failure or left ventricular ejection fraction (LVEF) ≤40% within 6 months before surgery
  • Diabetes mellitus and urine albumin-to-creatinine ratio >30 mg/g creatinine
  • Peripheral arterial disease
  • Anemia, defined as hemoglobin <10 g/dl
  • Prior cardiac surgery

Exclusion criteria

  • Any of the following laboratory abnormalities at the time of screening:
  • ALT >3-fold the upper limit of normal
  • eGFR <30 ml/min/1.73m2 or ESKD on dialysis
  • Hemoglobin <8 g/dl
  • History of gastric bypass or malabsorption
  • Active alcohol or illicit substance use in the prior 6 months
  • Participation in an investigational trial to evaluate pharmaceuticals or biologics within the past 3 months or 5 half-lives, whichever is shorter
  • Pregnant or breast-feeding
  • 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
  • Current use of niacin >100 mg/day or NMN, nicotinamide, or nicotinamide riboside at any dose
  • Conflict with other research studies
  • Any condition which, in the judgement of the investigator, might increase the risk to the participant

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Brigham and Women's Hospital — Boston

Identifiers

NCT: NCT07013591 · 2025P000420 · 1U01AG089040-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗