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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Adult patients (≥18 years) who are candidates for isolated CABG

• Patients who provided written informed consent and are willing to participate in the study

Locations
Other Locations
Islamic Republic of Iran
Rajaie Cardiovascular Medical & Research Center
RECRUITING
Tehran
Tehran Heart Center
RECRUITING
Tehran
Contact Information
Primary
Hessam Kakavand, PharmD
hessamkakavand@yahoo.com
+982144605351
Backup
Maryam Aghakouchakzadeh, PharmD
m.aghakouchakzadeh@gmail.com
+982188029600
Time Frame
Start Date: 2023-11-07
Estimated Completion Date: 2024-12-30
Participants
Target number of participants: 492
Treatments
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
Sponsors
Collaborators: Tehran Heart Center
Leads: Rajaie Cardiovascular Medical and Research Center

This content was sourced from clinicaltrials.gov