Niacinamide for Heart Injury After Surgery

This study is looking at whether niacinamide, a form of vitamin B3, can help prevent heart muscle injury (myocardial injury) and kidney injury after heart surgery. You might be able to join if you are an adult (18 years or older) scheduled for certain non-emergency heart surgeries that use a heart-lung machine (CPB). These surgeries include bypass surgery (CABG) or valve repair/replacement. Participants will receive either niacinamide (3 grams) or a placebo (an inactive substance that looks like the drug) on the day of surgery and for two days afterward. The main goal is to see if niacinamide reduces the amount of a heart injury marker called Troponin T in your blood for up to three days after surgery. The current recruitment status is unclear.

Study design
This is a randomized, double-blind study with 304 planned participants, meaning you would be randomly assigned to receive either niacinamide or a placebo, and neither you nor your doctors would know which you are receiving.
What's involved
You would receive niacinamide or placebo on the day of surgery and for two days after surgery.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for three months after the last patient enrolls.

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NCT04750616

NAD+ Augmentation in Cardiac Surgery Associated Myocardial Injury Trial

Recruiting
PHASE2Ages 18+InterventionalPrevention
Kaiser Permanente
~304 participants
Updated 2025-03-12 on ClinicalTrials.gov
What's tested:NiacinamidePlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Troponin T AUC
Measured over From baseline to three days after surgery
Ischemia Reperfusion Injury
Myocardial Injury
Acute Kidney Injury
1 sites across 1 states
California1

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Eligibility criteria

Inclusion

Informed consent before any study-related activities.
Men or women \>18 years of age who are scheduled for non-emergent cardiac surgery procedures requiring CPB and are at increased risk for surgery-related adverse cardiovascular outcomes.
CABG
Aortic, mitral, tricuspid, or pulmonic valve replacement or repair
CABG with aortic, mitral, tricuspid, and/or pulmonic valve replacement
Valve surgery
eGFR \< 45 ml/min/1.73m2
Documented LVEF ≤ 35% within six months before surgery
Documented history of heart failure
Insulin-requiring diabetes
Non-insulin-requiring diabetes and the presence of ≥+2 proteinuria on urinalysis (or equivalent on urine protein-to-creatinine ratio or urine albumin-to-creatinine ratio)
Preoperative anemia (hemoglobin \<11g/dl for men and women)
History of prior CABG
Age ≥65

Exclusion

Preexisting AKI within seven days before surgery as defined by KDIGO stage ≥1 (serum creatinine-based)
Kidney transplant status
Off-pump cardiac surgery
ESRD
Emergent cardiac surgery
Pregnancy
Patient enrolled in competing research studies that may affect outcomes
Patients held in an institution by legal or official order
  • Troponin T AUCFrom baseline to three days after surgery

    Troponin T AUC, composed of single daily serum measurements