Diabetes Mellitus, Type 2Phase 4POST-CABGDMNCT04523064
POST-CABGDM: Empagliflozin in Perioperative CABG
A Phase 4 study testing Empagliflozin 25 MG in people with Diabetes Mellitus, Type 2 and Coronary Artery Disease, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
Introduction: Diabetes Mellitus (DM) is a condition known to be associated with coronary artery disease (CAD) and its role as promoter of atherosclerosis is well stablished. The revascularization surgery is commonly indicated to patients with multivessel coronary disease and kidney injury is a prevalent complication… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Coronary Artery Disease, Coronary Artery Bypass Surgery
- What is being tested?
- Empagliflozin 25 MG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 1 siteBrazil
- Study dates
- 22 Sep 2020to 30 Jan 2024
- Phase
- Phase 4
- 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
- Age > 18
- Type 2 diabetes mellitus
- Multivessel CAD documented by coronary angiography with formal indication for CRM.
Who cannot join
- eGFR <30mL / min / 1.73m2 or dialysis therapy;
- Inability to sign the informed consent form;
- Contraindication to CABG on pump;
- Need for urgent or emergency CABG;
- Terminal or disabling illness with reduced life expectancy;
- Pregnancy in progress.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
University of Sao Paulo Medical School - The Heart Institute
São Paulo, São Paulo, 05403010
About this study
Official title: Empagliflozin for Prevention of Acute Kidney Injury in Patients With Type 2 Diabetes Mellitus Undergoing Extracorporeal On-pump CABG: The POST-CABGDM Trial
Introduction: Diabetes Mellitus (DM) is a condition known to be associated with coronary artery disease (CAD) and its role as promoter of atherosclerosis is well stablished. The revascularization surgery is commonly indicated to patients with multivessel coronary disease and kidney injury is a prevalent complication in post operation. This work aims to evaluate the impact of a strategy to control Diabetes Mellitus using inhibitors of sodium-glucose cotransporters (ISGLT2) in diabetics patients with assigned myocardial revascularization with cardiopulmonary bypass
Read the detailed description
Random Prospective Study non-blinded with 144 diabetics patients designated to myocardial revascularization with cardiopulmonary bypass . 72 patients will be randomly set to usual treatment provided by health care service and 72 patients will be randomly assigned treatment based on ISGLT2 (Empaglifozin). Patients will receive treatment as set for 3 months until 3 days prior to surgery. Creatinine levels will be measured immediately after surgery and in the following 3 days in post-op.
To evaluate the possibility to reduce the acute kidney injury in a randomized group treated with therapy based on ISGLT2.
- Conditions
- Diabetes Mellitus, Type 2, Coronary Artery Disease, Coronary Artery Bypass Surgery, Acute Kidney Injury
- Being tested
- Empagliflozin 25 MG
- Keywords
- Diabetes, Coronary artery disease, SGLT2i, CABG, Acute kidney injury
- Medical subject headings
- Diabetes Mellitus, Type 2, Coronary Artery Disease, Acute Kidney Injury, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empagliflozin 25 MGDrug
Also called Jardiance 25 mg
Patients with diabetes waiting for surgery will receive empagliflozin for at least three months.
| Study group | Role | What they receive |
|---|---|---|
| SGLT2i (empagliflozin) | Active comparator | Empagliflozin 25 mg 1 time day for three months Receives: Drug: Empagliflozin 25 MG |
| Standard of care | No intervention | Standard care treatment of diabetes patients in our center |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute kidney injury
Development of post-CABG acute kidney injury according to RIFFLE or AKIN or KDIGO criteria
Measured: 3 months
Secondary outcomes (6)
Atrial fibrillation
Development of atrial fibrillation during hospital admission
Measured: 3 months
Pulmonary infection
Development of pulmonary infection during hospital admission
Measured: 3 months
Infection of surgical site
Development of infection of surgical site during hospital admission
Measured: 3 months
ICU readmission
Transfer to ICU during hospital admission
Measured: 3 months
Need for IV insulin
Need for IV insulin during hospital admission
Measured: 3 months
Myocardial Infarction Type 5
Occurence of myocardial infarction type 5 during admission
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start22 Sep 2020
- Primary completion30 Jan 2024
- Study completion30 Jan 2024
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 Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlos V Serrano, MD, PhD, Principal investigator, Instituto do Coração - Hospital das Clinicas FMUSP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04523064
- Sponsor's protocol ID
- 4957/19/176
- Acronym
- POST-CABGDM
- Status last verified
- Jun 2024
- First submitted
- 18 Aug 2020
- Last updated
- 10 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Popp VO, Pitta FG, de Brito GD, Popp JO, Carvalho LNS, Sampaio LPC, Rached FH, Mioto BM, Bolta PMP, Asdrubal Vilca Mejia O, Dallan LAO, Filho RK, Abizaid AAC, Serrano CV, Lima EG. Preoperative empagliflozin and ventricular remodeling after coronary artery bypass grafting in type 2 diabetes: a prespecified analysis of the POST-CABGDM randomized trial. Diabetol Metab Syndr. 2026 Jul 28;18(1):227. doi: 10.1186/s13098-026-02232-x.
PubMed 42958583
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empagliflozin for Prevention of Acute Kidney Injury in Patients With Type 2 Diabetes Mellitus Undergoing Extracorporeal On-pump CABG: The POST-CABGDM Trial
- ClinicalTrials.gov ID
- NCT04523064
- Acronym / sponsor ID
- POST-CABGDM / 4957/19/176
- Conditions
- Diabetes Mellitus, Type 2, Coronary Artery Disease, Coronary Artery Bypass Surgery, Acute Kidney Injury
- Keywords
- Diabetes, Coronary artery disease, SGLT2i, CABG, Acute kidney injury
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 22 Sep 2020 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 21 Aug 2020 (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.
Introduction: Diabetes Mellitus (DM) is a condition known to be associated with coronary artery disease (CAD) and its role as promoter of atherosclerosis is well stablished. The revascularization surgery is commonly indicated to patients with multivessel coronary disease and kidney injury is a prevalent complication in post operation. This work aims to evaluate the impact of a strategy to control Diabetes Mellitus using inhibitors of sodium-glucose cotransporters (ISGLT2) in diabetics patients with assigned myocardial revascularization with cardiopulmonary bypass
Detailed description
Random Prospective Study non-blinded with 144 diabetics patients designated to myocardial revascularization with cardiopulmonary bypass . 72 patients will be randomly set to usual treatment provided by health care service and 72 patients will be randomly assigned treatment based on ISGLT2 (Empaglifozin). Patients will receive treatment as set for 3 months until 3 days prior to surgery. Creatinine levels will be measured immediately after surgery and in the following 3 days in post-op.
To evaluate the possibility to reduce the acute kidney injury in a randomized group treated with therapy based on ISGLT2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SGLT2i (empagliflozin) | Active comparator | Drug: Empagliflozin 25 MGEmpagliflozin 25 mg 1 time day for three months |
| Standard of care | No intervention | –Standard care treatment of diabetes patients in our center |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18
- Type 2 diabetes mellitus
- Multivessel CAD documented by coronary angiography with formal indication for CRM.
Key exclusion criteria (6 listed)
- eGFR <30mL / min / 1.73m2 or dialysis therapy;
- Inability to sign the informed consent form;
- Contraindication to CABG on pump;
- Need for urgent or emergency CABG;
- Terminal or disabling illness with reduced life expectancy;
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 |
|---|---|---|
| Empagliflozin 25 MGAlso: Jardiance 25 mgPatients with diabetes waiting for surgery will receive empagliflozin for at least three months. | Drug | SGLT2i (empagliflozin) |
Primary outcome
Acute kidney injury
Time frame: 3 months
Development of post-CABG acute kidney injury according to RIFFLE or AKIN or KDIGO criteria
6 secondary outcomes
Atrial fibrillation
Time frame: 3 months
Pulmonary infection
Time frame: 3 months
Infection of surgical site
Time frame: 3 months
ICU readmission
Time frame: 3 months
Need for IV insulin
Time frame: 3 months
Myocardial Infarction Type 5
Time frame: 3 months
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 10 Jun 2024.
- Derived from this study: PubMed 42958583Popp VO, Pitta FG, de Brito GD, Popp JO, Carvalho LNS, Sampaio LPC, Rached FH, Mioto BM, Bolta PMP, Asdrubal Vilca Mejia O, Dallan LAO, Filho RK, Abizaid AAC, Serrano CV, Lima EG. Preoperative empagliflozin and ventricular remodeling after coronary artery bypass grafting in type 2 diabetes: a prespecified analysis of the POST-CABGDM randomized trial. Diabetol Metab Syndr. 2026 Jul 28;18(1):227. doi: 10.1186/s13098-026-02232-x.
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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.
Carlos V Serrano, MD, PhD principal investigator
Instituto do Coração - Hospital das Clinicas FMUSP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Empagliflozin 25 MG in people with Diabetes Mellitus, Type 2 and Coronary Artery Disease, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 3 inclusion and 6 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 10 Jun 2024. 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 Brazil. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Acute kidney injury (time frame: 3 months). 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 NCT04523064, 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 10 Jun 2024.