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Evaluation of the efficacy and safety of Dapagliflozin in the prevention of post-CABG atrial fibrillation

Evaluation of the efficacy and safety of Dapagliflozin in the prevention of post-CABG atrial fibrillation: a randomized double-blind placebo- controlled trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200328046886N9
Enrollment
100
Registered
2026-05-03
Start date
2026-05-22
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative atrial fibrillation (POAF). Atrial fibrillation and flutter

Interventions

Intervention 1: Intervention group: patients will receive dapagliflozin 10 mg (manufactured by Tehran Chemie Pharmaceutical Company) once daily from three days before surgery until three days after su

Sponsors

Mazandaran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Individuals aged =18 years and <80 years Patients with angiographically confirmed coronary artery disease who are candidates for coronary artery bypass graft (CABG) surgery

Exclusion criteria

Exclusion criteria: History of type 1 diabetes mellitus Presence of a permanent pacemaker Severe heart failure (left ventricular ejection fraction [LVEF] 3 times the upper limit of normal (ULN) History of treatment with dapagliflozin or other sodium–glucose cotransporter-2 (SGLT2) inhibitors within 2 weeks prior to surgery Underweight status defined as a body mass index (BMI) =18.5 kg/m² Atrial fibrillation (AF) Pregnancy or breastfeeding History of recurrent urinary tract infections History of diabetic ketoacidosis (DKA) Hemodynamic instability Known hypersensitivity to dapagliflozin

Design outcomes

Primary

MeasureTime frame
Incidence of postoperative atrial fibrillation: any atrial fibrillation episode lasting more than 30 seconds recorded by ECG will be considered atrial fibrillation. Timepoint: The primary outcome will be assessed using continuous ECG monitoring from the time of CABG until 72 hours postoperatively. Method of measurement: using continuous electrocardiography (ECG) monitoring.

Secondary

MeasureTime frame
Incidence of the composite ventricular arrhythmia outcome: any episode of ventricular tachycardia and/or ventricular fibrillation lasting at least 30 seconds, detected by ECG monitoring, will be considered a ventricular arrhythmia. Timepoint: will be assessed using continuous ECG monitoring from the time of CABG until 72 hours postoperatively. Method of measurement: using continuous electrocardiography (ECG) monitoring.;Incidence of each type of ventricular arrhythmia assessed separately. Timepoint: will be assessed using continuous ECG monitoring from the time of CABG until 72 hours postoperatively. Method of measurement: using continuous electrocardiography (ECG) monitoring.;CRP level. Timepoint: A blood sample will be obtained by the nurse before surgery and on the third postoperative day to assess CRP levels. Method of measurement: Blood sample analysis using the Immunoturbidimetric method.;Length of ICU stay. Timepoint: From the time of CABG surgery to ICU discharge. Method of measurement: Checklist.;Serum creatinine level. Timepoint: Blood samples for serum creatinine measurement will be obtained by the nurse at baseline before surgery and then daily for up to three days postoperatively. Method of measurement: Blood sample analysis using the Jaffe method.;28-day mortality. Timepoint: The 28-day mortality rate after discharge will be followed up by the clinical pharmacy assistant via telephone contact. Method of measurement: telephone contact.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHamideh Abbaspour Kasgari

Mazandaran University of Medical Sciences

dr.abbaspour1@yahoo.com+98 11 4203 1035

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026