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Empagliflozin to Prevent Post-Operative Atrial Fibrillation

NCT ID: NCT06124937

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

492 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-07

Study Completion Date

2024-12-30

Brief Summary

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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

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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

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Post-operative Atrial Fibrillation CABG

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two arms, parallel-group, phase 3, randomized, double-blind, placebo-controlled trial with allocation sequence concealment and blinded endpoint adjudication on 492 patients
Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Neither the participants nor the researchers know which treatment or intervention patients are receiving

Study Groups

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Intervention group

The intervention group will receive a 10 mg tablet of empagliflozin once a day from 3 days before surgery until discharge from the hospital.

Group Type EXPERIMENTAL

Empagliflozin 10 MG

Intervention Type DRUG

The intervention group will receive a 10 mg tablet of empagliflozin once a day from 3 days before surgery until discharge from the hospital.

Comperator

The comparator group will receive a matching placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

The comparator group will receive a matching placebo from 3 days before surgery until discharge from the hospital.

Interventions

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Empagliflozin 10 MG

The intervention group will receive a 10 mg tablet of empagliflozin once a day from 3 days before surgery until discharge from the hospital.

Intervention Type DRUG

Placebo

The comparator group will receive a matching placebo from 3 days before surgery until discharge from the hospital.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult patients (≥18 years) who are candidates for isolated CABG
* Patients who provided written informed consent and are willing to participate in the study

Exclusion Criteria

* 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)
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tehran Heart Center

OTHER

Sponsor Role collaborator

Rajaie Cardiovascular Medical and Research Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tehran Heart Center

Tehran, , Iran

Site Status RECRUITING

Rajaie Cardiovascular Medical & Research Center

Tehran, , Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Hessam Kakavand, PharmD

Role: CONTACT

[email protected]
+982144605351

Maryam Aghakouchakzadeh, PharmD

Role: CONTACT

[email protected]
+982188029600

Facility Contacts

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Maryam Aghakouchakzadeh, PharmD

Role: primary

[email protected]
+982188029600

Hessam Kakavand, PharmD

Role: primary

[email protected]
+98 21 23921

Other Identifiers

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IRCT20230110057098N1

Identifier Type: -

Identifier Source: org_study_id