Cardiac Surgery-Associated Acute Kidney Injury.
Florian G Scurt, Katrin Bose, Peter R Mertens...
https://pubmed.ncbi.nlm.nih.gov/38689404Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID04750616
NAD+ Augmentation in Cardiac Surgery Associated Myocardial Injury (NACAM) Trial
Led by Kaiser Permanente · Updated on 2025-03-12
304
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
K
Kaiser Permanente
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of oral niacinamide (Nam) in preventing acute kidney injury and myocardial injury in patients undergoing on-pump cardiac surgery. This randomized, double-blind, placebo-controlled Phase 2 trial focuses on adults at increased risk for surgery-related cardiovascular complications, including those with chronic kidney disease or heart failure. The study is sponsored by Kaiser Permanente and aims to assess the impact of Nam on heart and kidney function after surgery. Participants will be randomly assigned to receive either 3 grams of niacinamide or a matched placebo on the day of surgery and the following two post-surgical days. The trial includes patients undergoing various cardiac surgeries such as coronary artery bypass grafting (CABG) and valve replacements or repairs. Patients are stratified by kidney function and surgical site to ensure balanced groups. The overall study duration spans 42 months with 39 months dedicated to recruitment and treatment and 3 months of follow-up. During the study, participants will be monitored closely with measurements including Troponin T area under the curve (AUC) from baseline to three days after surgery, as well as kidney function markers such as estimated glomerular filtration rate (eGFR) through day 5. Researchers will also track changes in urine biomarkers related to kidney injury. The study uses quadruple masking to maintain blinding of participants and researchers. Safety and efficacy data collected will help evaluate the potential of niacinamide to reduce surgery-related heart and kidney damage.
CONDITIONS
Brief Title
NAD+ Augmentation in Cardiac Surgery Associated Myocardial Injury Trial
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Provided informed consent before any study-related activities
- Men or women over 18 years of age
- Scheduled for non-emergent cardiac surgery requiring cardiopulmonary bypass, including CABG or valve replacement/repair
- At increased risk for surgery-related cardiovascular outcomes, defined by one or more of: valve surgery, eGFR below 45 ml/min/1.73m2, LVEF 35% or less within 6 months, history of heart failure, insulin-requiring diabetes, non-insulin diabetes with significant proteinuria, preoperative anemia (hemoglobin less than 11 g/dl), prior CABG, or age 65 or older
You will not qualify if you...
- Acute kidney injury within 7 days before surgery
- Kidney transplant recipient
- Off-pump cardiac surgery
- End-stage renal disease
- Emergent cardiac surgery
- Pregnancy
- Enrollment in competing research studies affecting outcomes
- Legal or official institutional hold on patient
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - 3 days
Participants receive either oral niacinamide 3 grams or a matched placebo on the day of surgery and on the first and second days after surgery.
1 surgery day visit and 2 post-surgical visits
Follow-up
Duration - Up to 3 months after the last participant is enrolled
Participants are followed for safety and outcome assessments after the treatment period ends.
Trial Site Locations
Total: 1 location
1
Kaiser Permanente San Francisco Medical Center
San Francisco, California, United States, 94115
Actively Recruiting
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Research Team
A
Ali Poyan Mehr, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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