NAD+ Augmentation in Cardiac Surgery Associated Myocardial Injury Trial

Last updated: March 10, 2025
Sponsor: Kaiser Permanente
Overall Status: Active - Recruiting

Phase

2

Condition

Organ Transplant

Myocardial Ischemia

Kidney Disease

Treatment

Placebo

Niacinamide

Clinical Study ID

NCT04750616
1620125
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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:

  • CABG

  • 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

  • Age ≥65

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

  • ESRD

  • Emergent cardiac surgery

  • Pregnancy

  • Patient enrolled in competing research studies that may affect outcomes

  • Patients held in an institution by legal or official order

Study Design

Total Participants: 304
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
September 13, 2021
Estimated Completion Date:
June 30, 2025

Study 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.

Connect with a study center

  • Kaiser Permanente San Francisco Medical Center

    San Francisco, California 94115
    United States

    Active - Recruiting

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