NAD+ Augmentation in Cardiac Surgery Associated Myocardial Injury Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

304 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-13

Study Completion Date

2025-06-30

Brief Summary

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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

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Detailed Description

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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

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Ischemia Reperfusion Injury Myocardial Injury Acute Kidney Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Oral niacinamide

Group Type EXPERIMENTAL

Niacinamide

Intervention Type DRUG

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

Matched placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Niacinamide

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No