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

Who is this study for? Patients with Ischemia Reperfusion, Myocardial, Acute Kidney Injury
What treatments are being studied? Niacinamide
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
Kaiser Permanente San Francisco Medical Center
RECRUITING
San Francisco
Contact Information
Primary
Ali Poyan Mehr, MD
ali.x.poyanmehr@kp.org
4152644750
Time Frame
Start Date: 2021-09-13
Estimated Completion Date: 2025-06-30
Participants
Target number of participants: 304
Treatments
Experimental: Oral niacinamide
Placebo_comparator: Matched placebo
Related Therapeutic Areas
Sponsors
Leads: Kaiser Permanente
Collaborators: Cedars-Sinai Medical Center, Beth Israel Deaconess Medical Center, National Heart, Lung, and Blood Institute (NHLBI)

This content was sourced from clinicaltrials.gov