Efficacy of DApagliflozin on REcurrence After Catheter Ablation for Atrial Fibrillation

2024-4-20610

This is a single-center, parallel-group, randomized, open-label trial evaluating the effect of 3-month treatment with dapagliflozin 10mg once daily on the recurrence of atrial fibrillation after catheter ablation for atrial fibrillation in patients without diabetes, heart failure, or chronic kidney disease.

2024-06-01

2025-08-01

2026-04-01

Not yet recruiting

200

Inclusion Criteria: 1. age between 18-80 years diagnosed with atrial fibrillation based on ECG or Holter 2. persistent atrial fibrillation 3. prepare to undergo initial catheter ablation for atrial fibrillation 4. agree to enrollment, randomization, treatment, and follow-up Exclusion Criteria: 1. diagnosed with persistent atrial fibrillation longer than 5 years or left atrial anterior-posterior diameter ≥ 50mm 2. diagnosed with atrial fibrillation secondary to reversible causes (such as hyperthyroidism, acute infection, etc.) 3. severe structural heart disease (hypertrophic cardiomyopathy, rheumatic heart disease, dilated cardiomyopathy, etc.) 4. currently take sodium-glucose co-transporter 2 inhibitors 5. complicated with the following Class I indications for sodium-glucose co-transporter 2 inhibitors: i. patients with type 2 diabetes with atherosclerotic cardiovascular disease (ASCVD) or at high risk for ASCVD ii. patients with a history of heart failure (HF), including HF with reduced ejection fraction, mildly reduced ejection fraction, and preserved ejection fraction iii. patients with chronic kidney disease with eGFR=20-60 ml/min/1.73m2 6. complicated with the following contraindication of sodium-glucose co-transporter 2 inhibitors: i. with previous allergic reactions to dapagliflozin ii. with end-stage renal failure or dialysis 7. type 1 diabetes, or previous diabetic ketoacidosis 8. severe hypoglycemia or genitourinary infection in the past 12 months 9. hypovolemia or hypotension 10. currently enrolled in another clinical study.

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}

2024-05-29