Post-operative Atrial FibrillationPhase 3EMPOAFNCT06124937
Empagliflozin to Prevent Post-Operative Atrial Fibrillation
A Phase 3 study testing Empagliflozin 10 MG in people with Post-operative Atrial Fibrillation and CABG, run by Rajaie Cardiovascular Medical and Research Center at 2 sites in Iran.
Trial summary
This is an interventional, double-blind, placebo controlled, multicenter, randomized clinical trial with allocation sequence concealment and blinded endpoint adjudication. The goal of present study is to investigate if periprocedural administration of 10 mg once daily empagliflozin, a sodium-glucose cotransporter-2… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Post-operative Atrial Fibrillation, CABG
- What is being tested?
- Empagliflozin 10 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 492 participants
- Where
- 2 sitesIran
- Study dates
- 7 Nov 2023to 30 Dec 2024
- Phase
- Phase 3
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (≥18 years) who are candidates for isolated CABG
- Patients who provided written informed consent and are willing to participate in the study
Who cannot join
- History of type Ⅰ or Ⅱ diabetes mellitus
- History of ketoacidosis
- History of atrial fibrillation or flutter
- History of recurrent UTI
- SGLT2I or any other oral hypoglycemic medications used due to other indications
- Patients with acute kidney injury (45)
Show all 14Show fewer
- Severe hepatic disease (Child-Pugh score C)
- Patients with Estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73m2
- Patients who are candidates for emergent CABG
- Patients with unstable hemodynamic state
- Patients with positive urine culture, urinary symptoms (frequency, dysuria, hesitancy), and asymptomatic bacteriuria
- Patients who are enrolled in other clinical trials
- Patients with a history of drug-sensitive reactions to SGLT2I
- Pregnancy or lactation
Trial locations and contacts
2 sites in 1 country.
Iran2 sites, 2 recruiting
- Recruiting
Tehran Heart Center
Tehran, 1411713138
Maryam Aghakouchakzadeh, PharmD, +982188029600, m.aghakouchakzadeh@gmail.com
- Recruiting
Rajaie Cardiovascular Medical & Research Center
Tehran, 1995614331
Hessam Kakavand, PharmD, +98 21 23921, hessamkakavand@yahoo.com
About this study
Official title: Evaluating the Role of EMpagliflozin on the Rate of Post-Operative Atrial Fibrillation in Patients Undergoing Coronary Artery Bypass Graft Surgery: a Double-blind Placebo-controlled Randomized Clinical Trial
This is an interventional, double-blind, placebo controlled, multicenter, randomized clinical trial with allocation sequence concealment and blinded endpoint adjudication. The goal of present study is to investigate if periprocedural administration of 10 mg once daily empagliflozin, a sodium-glucose cotransporter-2 inhibitor (SGLT2I), can reduce the incidence of post-operative atrial fibrillation and/or atrial flutter in patients with chronic coronary syndrome scheduled for isolated CABG. This trial will be conducted in two referral teaching cardiology hospitals in Tehran. 492 adult patients who are scheduled for elective isolated coronary artery bypass graft (CABG) surgery will be randomly assigned to one of the groups of intervention (empagliflozin 10 mg daily) or placebo starting 3 days before surgery until discharge.
Read the detailed description
Study aim: Evaluating the role of empagliflozin on the rate of postoperative atrial fibrillation in comparison with placebo Design: Two arms, parallel-group, phase 3, randomized, double-blind, placebo-controlled trial on 492 patients Settings and conduct: Recruitment site: Tehran Heart Center and Rajaie Cardiovascular Medical and Research Center For blinding, the drug or placebo will be given to the ward based on the patient's code in the randomization system For monitoring, the blood samples for creatinine, sodium, potassium, and fasting blood sugar along with clinical evaluations will be given on day 0 and daily thereafter (max= 30 days) in specific wards and will be compared at the end of any atrial fibrillation lasting longer than 30 seconds based on 24-hour 12-lead ECG monitoring will be accepted as atrial fibrillation After entering the study, the patients are placed in one of two groups, sample and control; in the sample group, they are treated with the usual treatment regimen plus empagliflozin at a dose of 10 mg during the hospitalization period. Patients in the control arm will receive a matching placebo.
- Conditions
- Post-operative Atrial Fibrillation, CABG
- Being tested
- Empagliflozin 10 MG, Placebo
- Keywords
- Atrial Fibrillation, CABG, Cardiac surgery, Empagliflozin, Post-operative AF, SGLT2 inhibitors
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empagliflozin 10 MGDrug
The intervention group will receive a 10 mg tablet of empagliflozin once a day from 3 days before surgery until discharge from the hospital.
PlaceboDrug
The comparator group will receive a matching placebo from 3 days before surgery until discharge from the hospital.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention group will receive a 10 mg tablet of empagliflozin once a day from 3 days before surgery until discharge from the hospital. Receives: Drug: Empagliflozin 10 MG |
| Comperator | Placebo comparator | The comparator group will receive a matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of POAF
Incidence of new-onset postoperative atrial fibrillation (AF) and/or atrial flutter (AFL), defined as any adjudicated documented AF or AFL of at least 30 seconds duration and documented by Holter ECG monitoring during the admission time in the ICU (at least 72 hours and maximum 30 days).
Measured: From CABG until discharge from the intensive care unit (at least 72 hours and maximum 30 days)
Secondary outcomes (12)
Composite Incidence of all arrhythmias leading to hemodynamic instability
Defined as any adjudicated documented tachy- or bradyarrhythmia of at least 30 seconds duration and documented by rhythm strips or 12-lead ECG leading to hemodynamic instability during the admission time. Ventricular tachycardia (VT) of at least 30 seconds duration and documented by rhythm strip or 12-lead ECG.
Ventricular fibrillation (VF) of at least 30 seconds duration and documented by rhythm strip or 12-lead ECG
Measured: From CABG until discharge from the hospital (maximum 30 days).
Incidence of post-operative acute kidney injury
Defined as the presence of either the increase in serum creatinine by ≥ 0.3 mg/dl (≥ 26.5 µmol/l) within 48 hours; or an increase in serum creatinine to ≥ 1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or urine volume < 0.5 ml/kg/h for 6 hours based on the KDIGO definition of AKI
Measured: From CABG until 7th post-operation day.
Need for vasopressor/inotrope
Defined as cumulative vasopressor index and the amount of average daily inotrope dose during the admission time in the ICU
Measured: From CABG until discharge from the intensive care unit (maximum 30 days).
Duration of hospitalization
Defined as number of days a patient stay at the hospital
Measured: From CABG until discharge from the hospital.
All-cause mortality
Defined as adjudicated 30-day mortality, including cause-specific mortality: cardiac arrhythmic, cardiac non-arrhythmic, and non-cardiovascular.
Measured: From CABG until 30th post-operation day.
Incidence of life-threatening infections
Defined as any adjudicated laboratory and clinically confirmed systemic infection that necessitate the administration of parenteral broad spectrum antibiotics
Measured: From CABG until discharge (maximum 30 days).
Incidence of genitourinary tract infections
Defined as any adjudicated laboratory and clinically confirmed genitourinary tract infection including cystitis, pyelonephritis, prostatitis, urethritis, and vaginitis
Measured: From CABG until discharge from the hospital (maximum 30 days).
Incidence of hypoglycemia
Defined as serum blood sugar ≤ 70 mg/dL (≤ 3.9 mmol/L)
Measured: From CABG until discharge from the hospital (maximum 30 days).
Incidence of ketoacidosis
Defined as blood pH ≤ 7.3, serum bicarbonate less than 15 mEq/l, and presence of ketonemia or ketonuria
Measured: From CABG until discharge from the hospital (maximum 30 days).
Incidence of clinically-diagnosed ischemic stroke
Defined as the sudden loss of blood circulation to an area of the brain that has been confirmed with appropriate diagnostic imaging (Brain CT/MRI)
Measured: From CABG until 30th post-operation day.
Composite incidence of arterial and venous thrombosis
Defined as adjudicated arterial thrombosis (including Type I MI and peripheral arterial thrombosis) and venous thrombosis (including DVT and PE) confirmed with appropriate diagnostic tools
Measured: From CABG until 30th post-operation day.
Need for renal replacement therapy
defined as treatment with any forms of dialysis (hemodialysis, hemodiafiltration, and peritoneal dialysis), hemofiltration, and renal transplantation
Measured: From CABG until discharge from the intensive care unit (maximum 30 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start7 Nov 2023
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative Atrial FibrillationStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two arms, parallel-group, phase 3, randomized, double-blind, placebo-controlled trial with allocation sequence concealment and blinded endpoint adjudication on 492 patients
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 492 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rajaie Cardiovascular Medical and Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Tehran Heart Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06124937
- Sponsor's protocol ID
- IRCT20230110057098N1
- Acronym
- EMPOAF
- Status last verified
- Nov 2023
- First submitted
- 23 Oct 2023
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Role of EMpagliflozin on the Rate of Post-Operative Atrial Fibrillation in Patients Undergoing Coronary Artery Bypass Graft Surgery: a Double-blind Placebo-controlled Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06124937
- Acronym / sponsor ID
- EMPOAF / IRCT20230110057098N1
- Conditions
- Post-operative Atrial Fibrillation, CABG
- Keywords
- Atrial Fibrillation, CABG, Cardiac surgery, Empagliflozin, Post-operative AF, SGLT2 inhibitors
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 492 participants (estimated)
- Lead sponsor
- Rajaie Cardiovascular Medical and Research CenterUniversity, hospital or other
- Collaborators
- Tehran Heart Center
- Study start
- 7 Nov 2023 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 9 Nov 2023 (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.
This is an interventional, double-blind, placebo controlled, multicenter, randomized clinical trial with allocation sequence concealment and blinded endpoint adjudication. The goal of present study is to investigate if periprocedural administration of 10 mg once daily empagliflozin, a sodium-glucose cotransporter-2 inhibitor (SGLT2I), can reduce the incidence of post-operative atrial fibrillation and/or atrial flutter in patients with chronic coronary syndrome scheduled for isolated CABG. This trial will be conducted in two referral teaching cardiology hospitals in Tehran. 492 adult patients who are scheduled for elective isolated coronary artery bypass graft (CABG) surgery will be randomly assigned to one of the groups of intervention (empagliflozin 10 mg daily) or placebo starting 3 days before surgery until discharge.
Detailed description
Study aim: Evaluating the role of empagliflozin on the rate of postoperative atrial fibrillation in comparison with placebo Design: Two arms, parallel-group, phase 3, randomized, double-blind, placebo-controlled trial on 492 patients Settings and conduct: Recruitment site: Tehran Heart Center and Rajaie Cardiovascular Medical and Research Center For blinding, the drug or placebo will be given to the ward based on the patient's code in the randomization system For monitoring, the blood samples for creatinine, sodium, potassium, and fasting blood sugar along with clinical evaluations will be given on day 0 and daily thereafter (max= 30 days) in specific wards and will be compared at the end of any atrial fibrillation lasting longer than 30 seconds based on 24-hour 12-lead ECG monitoring will be accepted as atrial fibrillation After entering the study, the patients are placed in one of two groups, sample and control; in the sample group, they are treated with the usual treatment regimen plus empagliflozin at a dose of 10 mg during the hospitalization period. Patients in the control arm will receive a matching placebo.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two arms, parallel-group, phase 3, randomized, double-blind, placebo-controlled trial with allocation sequence concealment and blinded endpoint adjudication on 492 patients
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: Empagliflozin 10 MGThe intervention group will receive a 10 mg tablet of empagliflozin once a day from 3 days before surgery until discharge from the hospital. |
| Comperator | Placebo comparator | Drug: PlaceboThe comparator group will receive a matching placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients (≥18 years) who are candidates for isolated CABG
- Patients who provided written informed consent and are willing to participate in the study
Key exclusion criteria (14 listed)
- History of type Ⅰ or Ⅱ diabetes mellitus
- History of ketoacidosis
- History of atrial fibrillation or flutter
- History of recurrent UTI
- SGLT2I or any other oral hypoglycemic medications used due to other indications
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 10 MGThe intervention group will receive a 10 mg tablet of empagliflozin once a day from 3 days before surgery until discharge from the hospital. | Drug | Intervention group |
| PlaceboThe comparator group will receive a matching placebo from 3 days before surgery until discharge from the hospital. | Drug | Comperator |
Primary outcome
Incidence of POAF
Time frame: From CABG until discharge from the intensive care unit (at least 72 hours and maximum 30 days)
Incidence of new-onset postoperative atrial fibrillation (AF) and/or atrial flutter (AFL), defined as any adjudicated documented AF or AFL of at least 30 seconds duration and documented by Holter ECG monitoring during the admission time in the ICU (at least 72 hours and maximum 30 days).
12 secondary outcomes
Composite Incidence of all arrhythmias leading to hemodynamic instability
Time frame: From CABG until discharge from the hospital (maximum 30 days).
Incidence of post-operative acute kidney injury
Time frame: From CABG until 7th post-operation day.
Need for vasopressor/inotrope
Time frame: From CABG until discharge from the intensive care unit (maximum 30 days).
Duration of hospitalization
Time frame: From CABG until discharge from the hospital.
All-cause mortality
Time frame: From CABG until 30th post-operation day.
Incidence of life-threatening infections
Time frame: From CABG until discharge (maximum 30 days).
Incidence of genitourinary tract infections
Time frame: From CABG until discharge from the hospital (maximum 30 days).
Incidence of hypoglycemia
Time frame: From CABG until discharge from the hospital (maximum 30 days).
Incidence of ketoacidosis
Time frame: From CABG until discharge from the hospital (maximum 30 days).
Incidence of clinically-diagnosed ischemic stroke
Time frame: From CABG until 30th post-operation day.
Composite incidence of arterial and venous thrombosis
Time frame: From CABG until 30th post-operation day.
Need for renal replacement therapy
Time frame: From CABG until discharge from the intensive care unit (maximum 30 days).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Empagliflozin 10 MG in people with Post-operative Atrial Fibrillation and CABG, run by Rajaie Cardiovascular Medical and Research Center at 2 sites in Iran.
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 2 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Iran. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hessam Kakavand, PharmD (+982144605351, hessamkakavand@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of POAF (time frame: From CABG until discharge from the intensive care unit (at least 72 hours and maximum 30 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Nov 2023.