Trial of Oral Niacinamide to Prevent Acute Kidney Injury in Adults Undergoing On-Pump Cardiac Surgery at Increased Cardiovascular Risk

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.

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