Cardiac SurgeryPhase 2NCT07013591
Nicotinamide Mononucleotide in Patients Undergoing Cardiac Surgery
A Phase 2 study testing MIB-626 in people with Cardiac Surgery, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- MIB-626
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2026to 1 Jan 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Scheduled to undergo elective isolated CABG surgery and/or valve 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
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- Diabetes mellitus
- 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
- Peripheral arterial disease
- Anemia, defined as hemoglobin <10 g/dl
- Prior cardiac surgery
Who cannot join
- 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 malabsorption
- Active alcohol abuse or illicit substance use in the prior 6 months
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
David E Leaf, MD, 617-732-5951, deleaf@bwh.harvard.edu
Nancy Latham, PhD, 6179999195, nklatham@bwh.harvard.edu
About this study
Official title: Randomized Clinical Trial of Beta Nicotinamide Mononucleotide in Patients Undergoing Cardiac Surgery
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.
Read the detailed description
This is a phase 2a, randomized, double-blind, parallel-group, placebo-controlled clinical trial in adult patients undergoing elective cardiac 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 3 days postoperatively
Arm B: NMN 1,000 mg PO twice daily, administered for 2 days preoperatively, on the day of surgery, and for 3 days postoperatively
Arm C: Placebo PO twice daily, administered for 7 days preoperatively, on the day of surgery, and for 3 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.
- Conditions
- Cardiac Surgery
- Being tested
- MIB-626, Placebo
- Keywords
- cardiac surgery, cardiopulmonary bypass, nicotinamide, NMN, acute kidney injury, valve surgery
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIB-626Drug
An orally-administered stable crystalline tablet formulation of NMN
PlaceboOther
matching placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| NMN (MIB-626) for 7 days preoperatively, on day of surgery, and for 3 days postoperatively | Experimental | NMN (MIB-626) 1000 mg PO daily, for 7 days preoperatively, on day of surgery, and for 3 days postoperatively Receives: Drug: MIB-626 |
| NMN administered for 2 days preoperatively, on the day of surgery, and for 3 days postoperatively | Experimental | NMN (MIB-626) 1,000 mg PO twice daily, administered for 2 days preoperatively, on the day of surgery, and for 3 days postoperatively Receives: Drug: MIB-626 |
| Placebo | Placebo comparator | Placebo administered for 7 days preoperatively, on the day of surgery, and for 3 days postoperatively Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
NAD+ concentration in the myocardial tissue
NAD+ concentration in the myocardial tissue (right atrial appendage) obtained intraoperatively, measured using the validated NADome Quant assay
Measured: Intraoperatively (single time point)
Secondary outcomes (12)
Intracellular levels of NAD+ and related metabolites
NAD+, NADH, and related metabolite concentrations in discarded tissue collected intraoperatively, including right atrial appendage, internal mammary artery, sternal muscle, and fat
Measured: Intraoperatively (single time point)
Circulating levels of NAD+ and related metabolites
NAD+, NADH, and related metabolite concentrations in the circulation and in peripheral blood mononuclear cells
Measured: Baseline to day 90
Markers of cardiac injury/dysfunction
Circulating levels of cardiac troponin I, creatine kinase MB fraction (CKMB), and N-terminal pro-B-type natriuretic peptide (NT-pro-BNP)
Measured: Preoperatively, on ICU arrival, and on postoperative days 1-4
Acute kidney injury (AKI)
Incidence of acute kidney injury (AKI) defined according to the Kidney Disease Improving Global Outcomes (KDIGO) criteria as any of the following: 1) urine output <0.5 ml/kg/h for ≥6 consecutive hours (assessed within the first 48h or until the Foley catheter is removed, whichever occurs first); 2) an increase in SCr ≥0.3 mg/dl within the first 48h; 3) an increase in SCr ≥50% within the first 7 days; or 4) receipt of KRT within the first 7 days
Measured: 7 days post-operatively
Serum creatinine (SCr)
Maximum baseline-adjusted changes in SCr
Measured: Immediately pre-operative to 7 days post-operative
Cystatin C
Circulating levels of cystatin C
Measured: Preoperatively, on ICU arrival, and on postoperative days 1-4
Neutrophil gelatinase-associated lipocalin (NGAL)
Circulating levels of measured neutrophil gelatinase-associated lipocalin (NGAL)
Measured: Preoperatively, on ICU arrival, and on postoperative days 1-4
Kidney Injury Molecule-1 (KIM-1)
Circulating levels of KIM-1
Measured: Preoperatively, on ICU arrival, and on postoperative days 1-4
NMN level
Plasma concentrations of NMN
Measured: Preoperatively, on ICU arrival, and on postoperative days 1-4
2PY Level
Plasma concentrations of 2PY
Measured: Preoperatively, on ICU arrival, and on postoperative days 1-4
N-Methylnicotinamide level
Plasma N-methylynicotinamide level
Measured: Preoperatively, on ICU arrival, and on postoperative days 1-4
nicotinamide level
Plasma nicotinamide concentrations
Measured: Preoperatively, on ICU arrival, and on postoperative days 1-4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start10 Jun 2026
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Shalendar Bhasin, MD, Brigham and Women's Hospital
- Investigators
- Shalender Bhasin, MB, BS, Principal investigator, Brigham and Women's Hosptial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07013591
- Sponsor's protocol ID
- 2025P000420
- Other IDs
- 1U01AG089040-01
- Status last verified
- Aug 2026
- First submitted
- 9 May 2025
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: In accordance with the NIH Policy for Data Management and Sharing, as well as the NIH Genomic Data Sharing Policy, deidentified data generated from this research will be shared with the research community by depositing it in the Harvard Dataverse. This will include any large-scale genomic data generated.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Beta Nicotinamide Mononucleotide in Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT07013591
- Acronym / sponsor ID
- 2025P000420
- Conditions
- Cardiac Surgery
- Keywords
- cardiac surgery, cardiopulmonary bypass, nicotinamide, NMN, acute kidney injury, valve surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 10 Jun 2026 (actual)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 10 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a phase 2a, randomized, double-blind, parallel-group, placebo-controlled clinical trial in adult patients undergoing elective cardiac 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 3 days postoperatively
Arm B: NMN 1,000 mg PO twice daily, administered for 2 days preoperatively, on the day of surgery, and for 3 days postoperatively
Arm C: Placebo PO twice daily, administered for 7 days preoperatively, on the day of surgery, and for 3 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NMN (MIB-626) for 7 days preoperatively, on day of surgery, and for 3 days postoperatively | Experimental | Drug: MIB-626NMN (MIB-626) 1000 mg PO daily, for 7 days preoperatively, on day of surgery, and for 3 days postoperatively |
| NMN administered for 2 days preoperatively, on the day of surgery, and for 3 days postoperatively | Experimental | Drug: MIB-626NMN (MIB-626) 1,000 mg PO twice daily, administered for 2 days preoperatively, on the day of surgery, and for 3 days postoperatively |
| Placebo | Placebo comparator | Other: PlaceboPlacebo administered for 7 days preoperatively, on the day of surgery, and for 3 days postoperatively |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥18 years
- Scheduled to undergo elective isolated CABG surgery and/or valve surgery with cardiopulmonary bypass (CPB)
- At increased risk of postoperative complications based on ≥1 of the following:
Key exclusion criteria (12 listed)
- Any of the following laboratory abnormalities at the time of screening:
- History of malabsorption
- Active alcohol abuse 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MIB-626An orally-administered stable crystalline tablet formulation of NMN | Drug | NMN (MIB-626) for 7 days preoperatively, on day of surgery, and for 3 days postoperatively, NMN administered for 2 days preoperatively, on the day of surgery, and for 3 days postoperatively |
| Placebomatching placebo tablets | Other | Placebo |
Primary outcome
NAD+ concentration in the myocardial tissue
Time frame: Intraoperatively (single time point)
NAD+ concentration in the myocardial tissue (right atrial appendage) obtained intraoperatively, measured using the validated NADome Quant assay
12 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: Yes. In accordance with the NIH Policy for Data Management and Sharing, as well as the NIH Genomic Data Sharing Policy, deidentified data generated from this research will be shared with the research community by depositing it in the Harvard Dataverse. This will include any large-scale genomic data generated.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shalender Bhasin, MB, BS principal investigator
Brigham and Women's Hosptial
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MIB-626 in people with Cardiac Surgery, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shalender Bhasin, MB,BS (617-525-9150, sbhasin@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NAD+ concentration in the myocardial tissue (time frame: Intraoperatively (single time point)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.