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

Kaiser Permanente

Status and phase: Enrolling; Phase 2

Conditions: Acute Kidney Injury; Ischemia Reperfusion Injury; Myocardial Injury

Treatments: Drug: Placebo; Drug: Niacinamide

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04750616

1620125

Details and patient eligibility

About

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

Full 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.

Enrollment: 304 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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304 participants in 2 patient groups, including a placebo group

Oral niacinamide

Experimental group

Treatment:

Drug: Niacinamide

Matched placebo

Placebo Comparator group

Treatment:

Drug: Placebo