NCT04750616 · Kaiser Permanente
NAD+ Augmentation in Cardiac Surgery Associated Myocardial Injury Trial
(NACAM)
What this study is about
A randomly assigned, where neither patients nor doctors know which treatment is given, compared against an inactive treatment Trial to Evaluate the effectiveness of taken by mouth Nam for the Prevention of Acute Kidney Injury in Patients Undergoing On-Pump Cardiac Surgery
View original scientific description
A Randomized, Double-blind, placebo-controlled Trial to Evaluate the Efficacy of Oral Nam for the Prevention of Acute Kidney Injury in Patients Undergoing On-Pump Cardiac Surgery
Interventions
DRUG
Niacinamide
Niacinamide 3 grams on the day of surgery and post-surgical days one and two
DRUG
Placebo
Matched placebo on the day of surgery and post-surgical days one and two
Primary outcome measures
Troponin T AUC
Time frame: From baseline to three days after surgery
Troponin T AUC, composed of single daily serum measurements
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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. Procedures include:
- Aortic, mitral, tricuspid, or pulmonic valve replacement or repair
- CABG with aortic, mitral, tricuspid, and/or pulmonic valve replacement Risk factors for surgery related to adverse cardiovascular outcomes include one or more of the following:
- 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
Exclusion criteria
- Preexisting AKI within seven days before surgery as defined by KDIGO stage ≥1 (serum creatinine-based)
- Kidney transplant status
- Off-pump cardiac surgery
- Emergent cardiac surgery
- Patient enrolled in competing research studies that may affect outcomes
- Patients held in an institution by legal or official order
Where
- San Francisco, California
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Beth Israel Deaconess Medical Center, Cedars-Sinai Medical Center
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 12, 2025 · Source of record for eligibility and locations