Empagliflozin to Prevent Post-Operative Atrial Fibrillation

NCT06124937 | Unknown Phase 3 DMC

• 1 other identifier: IRCT20230110057098N1
• Study Type: interventional
• Target: 492
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Post-operative Atrial Fibrillation; CABG

Keywords

Atrial Fibrillation; CABG; Cardiac surgery; Empagliflozin; Post-operative AF; SGLT2 inhibitors

Outcome Measures

Primary Outcomes (1)

• 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).

  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

  From CABG until discharge from the hospital (maximum 30 days).

• Incidence of post-operative acute kidney injury

  From CABG until 7th post-operation day.

• Need for vasopressor/inotrope

  From CABG until discharge from the intensive care unit (maximum 30 days).

• Duration of hospitalization

  From CABG until discharge from the hospital.

• All-cause mortality

  From CABG until 30th post-operation day.

Study Arms (2)

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.

Drug: Empagliflozin 10 MG

Comperator

PLACEBO COMPARATOR

The comparator group will receive a matching placebo

Drug: Placebo

Interventions

Empagliflozin 10 MG 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.

Intervention group

Placebo DRUG

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

Comperator

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rajaie Cardiovascular Medical and Research Center: lead
• Tehran Heart Center: collaborator

Study Sites (2)

Tehran Heart Center

Tehran, 1411713138, Iran

RECRUITING

Rajaie Cardiovascular Medical & Research Center

Tehran, 1995614331, Iran

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Hessam Kakavand, PharmD

CONTACT

+982144605351; hessamkakavand@yahoo.com

Maryam Aghakouchakzadeh, PharmD

CONTACT

+982188029600; m.aghakouchakzadeh@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Neither the participants nor the researchers know which treatment or intervention patients are receiving
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: November 9, 2023
• Study Start: November 7, 2023
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: November 22, 2023

Record last verified: 2023-11

Locations

IR (2)