NCT06759909

Dapagliflozin on Outcomes of Rhythm Control Strategy (Pharmacological ± Interventional) in Patient with Atrial Fibrillation

Influence of Use of Dapagliflozin on Outcomes of Rhythm Control Strategy (Pharmacological ± Interventional) in Patient with Atrial Fibrillation

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

Investigator study the efficacy and safety outcomes of Dapagliflozin use among newly diagnosed Atrial fibrillation patients when underwent rhythm control strategy regardless their diabetic status.

Detailed description

Atrial fibrillation (AF) is the most common arrhythmia among adults with increasing risk of stroke, heart failure (HF) and mortality . Based on the EAST-AFNET 4 trial and nationwide cohort studies, early rhythm control treatment (Antiarrhythmic drugs AAD or catheter ablation) was associated with a lower risk of adverse cardiovascular outcomes than usual care among patients who had recently (within one year) been diagnosed with atrial fibrillation A new oral hypoglycemic drug, dapagliflozin, a sodium-glucose cotransporter-2 inhibitor (SGLT2i), was confirmed to reduce the risk of cardiovascular adverse events (AEs) and improve coronary heart disease and HF outcomes in multiple clinical trials . In addition, previous post hoc analyses and meta-analyses reported that dapagliflozin can decrease the incidence rate of new-onset AF Recent trials and meta-analyses have reported that SGLT2i can achieve greater suppression of AF recurrence after catheter ablation (CA) in T2DM patients . Nonetheless, it remains unknown whether dapagliflozin can improve the recurrence of AF among newly diagnosed AF patients who underwent rhythm control strategy regardless the diabetic status.

Conditions

• Dapagliflozin (Forxiga)
• Atrial Fibrillation (AF)

Interventions

Type	Name	Description
DRUG	Dapagliflozin (DAPA)	We will record all baseline characteristics (Age, sex, BMI, HR and BP), AF type, EHRA class, previous use of ADD (B blockers, Class I, III AAD), previous CV, prior cerebrovascular stroke and Co-morbidities (HTN, DM, IHD, HF, Renal impairment, peripheral arterial disease, OSAS). CHADS2Vasc score and HAS-BLEED score will be calculated. Trans-thoracic echocardiograms will be performed within 4 weeks before the rhythm control attempts to determine LA diameter and volumes and left ventricular hypertrophy and functions (EF and E/'e). After enrollment, the patients will be treated with dapagliflozin (10 mg/d) or placebo at the time of rhythm control strategy and will continue daily treatment at the same dose till the 9 month follow-up period.

Timeline

• Start date: 2025-01-03
• Primary completion: 2026-12-22
• Completion: 2028-12-22
• First posted: 2025-01-06
• Last updated: 2025-01-06