Ischemia Reperfusion InjuryPhase 2NACAMNCT04750616
NAD+ Augmentation in Cardiac Surgery Associated Myocardial Injury Trial
A Phase 2 study testing Niacinamide in people with Ischemia Reperfusion Injury and Myocardial Injury, run by Kaiser Permanente at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemia Reperfusion Injury, Myocardial Injury, Acute Kidney Injury
- What is being tested?
- Niacinamide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 331 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2021to 19 Jun 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 16Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente San Francisco Medical Center
San Francisco, California, 94115
About this study
Official title: NAD+ Augmentation in Cardiac Surgery Associated Myocardial Injury (NACAM) Trial
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
Read the 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.
- Being tested
- Niacinamide, Placebo
- Medical subject headings
- Reperfusion Injury, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NiacinamideDrug
Niacinamide 3 grams on the day of surgery and post-surgical days one and two
PlaceboDrug
Matched placebo on the day of surgery and post-surgical days one and two
| Study group | Role | What they receive |
|---|---|---|
| Oral niacinamide | Experimental | Not described Receives: Drug: Niacinamide |
| Matched placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Troponin T AUC
Troponin T AUC, composed of single daily serum measurements
Measured: From baseline to three days after surgery
Secondary outcomes (2)
Mean difference in uQuin/Tryp ratio AUC
Mean difference in uQuin/Tryp ratio AUC composed of single daily serum measurements
Measured: From baseline to three days after surgery
Mean difference in eGFR
Mean difference in eGFR (CKD-EPI formula)
Measured: From baseline through day 5.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start13 Sep 2021
- Primary completion19 Jun 2026
- Study completion19 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemia Reperfusion InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 331 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Beth Israel Deaconess Medical Center, Cedars-Sinai Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04750616
- Sponsor's protocol ID
- 1620125
- Acronym
- NACAM
- Status last verified
- Oct 2026
- First submitted
- 29 Jan 2021
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38689404
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NAD+ Augmentation in Cardiac Surgery Associated Myocardial Injury (NACAM) Trial
- ClinicalTrials.gov ID
- NCT04750616
- Acronym / sponsor ID
- NACAM / 1620125
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 331 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Beth Israel Deaconess Medical Center, Cedars-Sinai Medical Center
- Study start
- 13 Sep 2021 (actual)
- Primary completion
- 19 Jun 2026 (actual)
- Study completion
- 19 Jun 2026 (actual)
- First posted
- 11 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral niacinamide | Experimental | Drug: Niacinamide |
| Matched placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
- CABG
- Aortic, mitral, tricuspid, or pulmonic valve replacement or repair
- CABG with aortic, mitral, tricuspid, and/or pulmonic valve replacement
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NiacinamideNiacinamide 3 grams on the day of surgery and post-surgical days one and two | Drug | Oral niacinamide |
| PlaceboMatched placebo on the day of surgery and post-surgical days one and two | Drug | Matched placebo |
Primary outcome
Troponin T AUC
Time frame: From baseline to three days after surgery
Troponin T AUC, composed of single daily serum measurements
2 secondary outcomes
Mean difference in uQuin/Tryp ratio AUC
Time frame: From baseline to three days after surgery
Mean difference in eGFR
Time frame: From baseline through day 5.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Derived from this study: PubMed 38689404Scurt 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Niacinamide in people with Ischemia Reperfusion Injury and Myocardial Injury, run by Kaiser Permanente at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Troponin T AUC (time frame: From baseline to three days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04750616, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.