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

Phase 1

Not yet recruiting

• Conditions: Dapagliflozin (Forxiga); Atrial Fibrillation (AF)
• Interventions: Drug: Dapagliflozin (DAPA)

• Registration Number: NCT06759909
• Lead Sponsor: Assiut University

Brief 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.

Study Timeline

• Study First Submitted: 2024-12-22
• Status Verified: 2025-01
• Study Start: 2025-01-03
• Study First Submitted QC: 2025-01-03
• Last Update Submitted: 2025-01-03
• Study First Posted: 2025-01-06
• Last Update Posted: 2025-01-06
• Primary Completion: 2026-12-22
• Study Completion: 2028-12-22

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Newly diagnosed AF patients (Time between AF diagnosis to rhythm control attempt less than one year) Paroxysmal and persistent atrial fibrillation (AF) documented on a 12 lead ECG, Holter monitor (episodes of AF must be >30 seconds in duration to qualify as an inclusion criterion) Age of 18 years or older on the date of consent. Informed Consent

Exclusion Criteria

• Long standing persistent AF. Previous use of dapagliflozin within one month of rhythm control attempt. Previous rhythm control attempt. AF due to reversible cause (e.g. hyperthyroidism, cardiothoracic surgery). History of congestive heart failure. Active intracardiac thrombus Pre-existing pulmonary vein stenosis or pulmonary vein stent Contraindication to anticoagulation or radio contrast materials

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dapagliflizon in Atrial fibrillation on Rythme control	Dapagliflozin (DAPA)	investigator study the efficacy and safety outcomes of Dapagliflozin use among newly diagnosed AF patients when underwent rhythm control strategy regardless their diabetic status. 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.

Primary Outcome Measures

Name	Time	Method
freedom from any atrial arrhythmia	9 month	The primary effectiveness endpoint is freedom from any atrial arrhythmia (atrial arrhythmia defined as Atrial fibrillation or atrial tachycardia \[AT\] that lasted ≥ 30 seconds on/off AAD detected by the monitoring tools during the follow-up period excluding the first three months of the blanking period).

Secondary Outcome Measures

Name	Time	Method
cardiovascular hospitalization	9 month	Cardiovascular hospitalizations are defined as any hospitalizations due to cardiovascular cause such as AF related hospitalizations (such as emergency department (ED) visits, repeat ablation, electrical cardioversion and AV nodal ablation), device implantations, and decompensated HF hospitalization, stroke, myocardial infarction, vascular complications and major bleedings.