NAD+ Augmentation in Cardiac Surgery Associated Myocardial Injury Trial

Phase 2

Recruiting

• Conditions: Ischemia Reperfusion Injury; Myocardial Injury; Acute Kidney Injury
• Interventions: Drug: Niacinamide; Drug: Placebo

• Registration Number: NCT04750616
• Lead Sponsor: Kaiser Permanente

Brief 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.

Study Timeline

• Study First Submitted: 2021-01-29
• Study First Submitted QC: 2021-02-10
• Study First Posted: 2021-02-11
• Study Start: 2021-09-13
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-12
• Primary Completion: 2025-04-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 304

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral niacinamide	Niacinamide	-
Matched placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Troponin T AUC	From baseline to three days after surgery	Troponin T AUC, composed of single daily serum measurements

Secondary Outcome Measures

Name	Time	Method
Mean difference in eGFR	From baseline through day 5.	Mean difference in eGFR (CKD-EPI formula)
Mean difference in uQuin/Tryp ratio AUC	From baseline to three days after surgery	Mean difference in uQuin/Tryp ratio AUC composed of single daily serum measurements

Trial Locations

Locations (1)

Kaiser Permanente San Francisco Medical Center; 🇺🇸 San Francisco, California, United States