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

Assiut University

Status and phase: Not yet enrolling; Phase 1

Conditions: Dapagliflozin (Forxiga); Atrial Fibrillation (AF)

Treatments: Drug: Dapagliflozin (DAPA)

Study type: Interventional

Funder types: Other

Identifiers

NCT06759909

Dapagliflozin in AF Patients

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Dapagliflizon in Atrial fibrillation on Rythme control

Active Comparator group

Description:

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.

Treatment:

Drug: Dapagliflozin (DAPA)