Recruiting
Phase 2

NAD+ Augmentation

Sponsor:

Kaiser Permanente

Code:

NCT04750616

Conditions

Ischemia Reperfusion Injury

Myocardial Injury

Acute Kidney Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Niacinamide

Placebo

Study Details

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

Conditions

Ischemia Reperfusion Injury

Myocardial Injury

Acute Kidney Injury

Study ID

NCT04750616

Start date

Sep 13, 2021

Status verified date

Mar, 2025

Completion date

Jun 30, 2025

Anticipated

Primary completion date

Apr 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

304 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Oral niacinamide

placebo comparator: Matched placebo

Interventions

Niacinamide

Niacinamide 3 grams on the day of surgery and post-surgical days one and two

Placebo

Matched placebo on the day of surgery and post-surgical days one and two

Primary outcome measure

  • Troponin T AUC [ Time Frame: From baseline to three days after surgery ]

Central Contacts and Locations

Central contacts

Ali Poyan Mehr, MD

4152644750ali.x.poyanmehr@kp.org

Locations

Kaiser Permanente San Francisco Medical Center

Recruiting

San Francisco, California, United States, 94115

More Information

Sponsor

Kaiser Permanente

Last update posted

Mar 12, 2025

Last verified

Mar, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Kaiser Permanente on 2025-03-12.