NCT04750616 NAD+ Augmentation in Cardiac Surgery Associated Myocardial Injury Trial
| NCT ID | NCT04750616 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Kaiser Permanente |
| Condition | Ischemia Reperfusion Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 304 participants |
| Start Date | 2021-09-13 |
| Primary Completion | 2025-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 304 participants in total. It began in 2021-09-13 with a primary completion date of 2025-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04750616 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Ischemia Reperfusion Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04750616 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04750616 currently recruiting?
Yes, NCT04750616 is actively recruiting participants. Contact the research team at ali.x.poyanmehr@kp.org for enrollment information.
Where is the NCT04750616 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT04750616 clinical trial?
NCT04750616 is sponsored by Kaiser Permanente. The trial plans to enroll 304 participants.