Empagliflozin to Prevent Post-Operative Atrial Fibrillation

Sponsor
Rajaie Cardiovascular Medical and Research Center
Study ID
NCT06124937
Phase
PHASE3
Status
Unknown

Conditions

  • CABG
  • Post-operative Atrial Fibrillation

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
Nov 7, 2023
Status verified
Nov 2023
Primary completion
Dec 30, 2024
Completion
Dec 30, 2024

Study Design

Enrollment
492 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: 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.
  • Placebo Comparator: Comperator
    The comparator group will receive a matching placebo

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) ]

Central Contacts

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