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

Primary Purpose

Ischemia Reperfusion Injury, Myocardial Injury, Acute Kidney Injury

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Niacinamide
Placebo
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ischemia Reperfusion Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kaiser Permanente San Francisco Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Oral niacinamide

Matched placebo

Arm Description

Outcomes

Primary Outcome Measures

Troponin T AUC
Troponin T AUC, composed of single daily serum measurements

Secondary Outcome Measures

Mean difference in uQuin/Tryp ratio AUC
Mean difference in uQuin/Tryp ratio AUC composed of single daily serum measurements
Mean difference in eGFR
Mean difference in eGFR (CKD-EPI formula)

Full Information

First Posted
January 29, 2021
Last Updated
July 14, 2023
Sponsor
Kaiser Permanente
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Beth Israel Deaconess Medical Center, Cedars-Sinai Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04750616
Brief Title
NAD+ Augmentation in Cardiac Surgery Associated Myocardial Injury Trial
Acronym
NACAM
Official Title
NAD+ Augmentation in Cardiac Surgery Associated Myocardial Injury (NACAM) Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 13, 2021 (Actual)
Primary Completion Date
April 30, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Beth Israel Deaconess Medical Center, Cedars-Sinai Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemia Reperfusion Injury, Myocardial Injury, Acute Kidney Injury

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
304 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oral niacinamide
Arm Type
Experimental
Arm Title
Matched placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Niacinamide
Intervention Description
Niacinamide 3 grams on the day of surgery and post-surgical days one and two
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matched placebo on the day of surgery and post-surgical days one and two
Primary Outcome Measure Information:
Title
Troponin T AUC
Description
Troponin T AUC, composed of single daily serum measurements
Time Frame
From baseline to three days after surgery
Secondary Outcome Measure Information:
Title
Mean difference in uQuin/Tryp ratio AUC
Description
Mean difference in uQuin/Tryp ratio AUC composed of single daily serum measurements
Time Frame
From baseline to three days after surgery
Title
Mean difference in eGFR
Description
Mean difference in eGFR (CKD-EPI formula)
Time Frame
From baseline through day 5.
Other Pre-specified Outcome Measures:
Title
Number of Participants with the following Adverse Events and Serious Adverse Events
Description
Postoperative dysrhythmias Postoperative re-hospitalization. Heart failure Surgical wound infection Transfusion requiring perioperative bleed Post-surgical deep vein thrombosis and pulmonary emboli Nosocomial infection Nausea and vomiting Adverse events leading to treatment discontinuation Perioperative liver injury (x2 upper normal-limit) Post-operative thrombosis and pulmonary emboli Impairment of renal function (KDIGO AKI)
Time Frame
From baseline through day 90
Title
Length of index hospital stay.
Description
• Mean length of index hospital stay (days)
Time Frame
From baseline through day 90
Title
Length of intensive care unit stay.
Description
• Mean length of intensive care unit stay (days)
Time Frame
From baseline through day 90
Title
Perioperative inotropic-score and vasoactive-inotropic score.
Description
• Mean inotropic-score and vasoactive-inotropic score
Time Frame
At 6, 12, 24, and 48 hours post operatively
Title
Perioperative fluid volume administration.
Description
• Mean daily perioperative fluid volume administration
Time Frame
From baseline through day 2
Title
Perioperative brain-natriuretic peptide AUC
Description
BNP AUC, composed of single daily serum measurements
Time Frame
From baseline to three days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ali Poyan Mehr, MD
Phone
4152644750
Email
ali.x.poyanmehr@kp.org
Facility Information:
Facility Name
Kaiser Permanente San Francisco Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Poyan Mehr, MD
First Name & Middle Initial & Last Name & Degree
Ahmad Sheikh, MD
First Name & Middle Initial & Last Name & Degree
Andrew Avins, MD
First Name & Middle Initial & Last Name & Degree
Lance Rtherford, MD
First Name & Middle Initial & Last Name & Degree
Paul LaPunzina, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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NAD+ Augmentation in Cardiac Surgery Associated Myocardial Injury Trial

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