NAD+ Augmentation in Cardiac Surgery Associated Myocardial Injury Trial

NCT04750616 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 1620125
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Troponin T AUC

  Troponin T AUC, composed of single daily serum measurements

  From baseline to three days after surgery

Secondary Outcomes (2)

• Mean difference in uQuin/Tryp ratio AUC

  From baseline to three days after surgery

• Mean difference in eGFR

  From baseline through day 5.

Other Outcomes (6)

• Number of Participants with the following Adverse Events and Serious Adverse Events

  From baseline through day 90

• Length of index hospital stay.

  From baseline through day 90

• Length of intensive care unit stay.

  From baseline through day 90

Study Arms (2)

Oral niacinamide

EXPERIMENTAL

Drug: Niacinamide

Matched placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Niacinamide DRUG

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

Oral niacinamide

Placebo DRUG

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

Matched placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaiser Permanente: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Beth Israel Deaconess Medical Center: collaborator
• Cedars-Sinai Medical Center: collaborator

Study Sites (1)

Kaiser Permanente San Francisco Medical Center

San Francisco, California, 94115, United States

RECRUITING

Related Publications (1)

• Scurt FG, Bose K, Mertens PR, Chatzikyrkou C, Herzog C. Cardiac Surgery-Associated Acute Kidney Injury. Kidney360. 2024 Jun 1;5(6):909-926. doi: 10.34067/KID.0000000000000466. Epub 2024 May 1.

  PMID: 38689404 DERIVED

MeSH Terms

Conditions

Reperfusion Injury; Acute Kidney Injury

Interventions

Niacinamide

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Ali Poyan Mehr, MD

CONTACT

4152644750; ali.x.poyanmehr@kp.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: February 11, 2021
• Study Start: September 13, 2021
• Primary Completion: April 30, 2025
• Study Completion: June 30, 2025
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)