NCT04750616

NAD+ Augmentation in Cardiac Surgery Associated Myocardial Injury Trial

NAD+ Augmentation in Cardiac Surgery Associated Myocardial Injury (NACAM) Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 304 (estimated)
• Sponsor: Kaiser Permanente · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This trial is a single-center, randomized, double-blind placebo-controlled Trial of Nam versus placebo in patients undergoing on-pump cardiac surgery. After screening and enrollment, patients will be stratified according to CKD status (eGFR\<45 ml/min/m2) and surgical site and randomized in a 1:1 manner to receive either Nam 3 grams or placebo on the day of surgery and post-surgical days one and two. The overall trial duration is planned for 42 months, consisting of 39 months of active recruitment and treatment period and three months of follow-up from the last patient enrolled.

Conditions

• Ischemia Reperfusion Injury
• Myocardial Injury
• Acute Kidney Injury

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-09-13
• Primary completion: 2025-04-30
• Completion: 2025-06-30
• First posted: 2021-02-11
• Last updated: 2025-03-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study