Efficacy of Dapagliflozin on Recurrence After Catheter Ablation for Atrial

Status Not yet recruiting

Clinical Trial Summary

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.

Clinical Trial Description

Atrial fibrillation (AF) is one of the most common arrhythmias. Catheter ablation of atrial fibrillation, as the main means of rhythm control, can effectively maintain sinus rhythm, reduce the recurrence of AF burden, and improve the patient's quality of life and prognosis. However, AF recurrence still occurs in 30-50% of patients after atrial fibrillation catheter ablation, and there is currently no effective strategy to reduce the recurrence rate after atrial fibrillation ablation. Sodium-glucose cotransporter 2 inhibitors (SGLT2i) are a new class of diabetic drugs and large clinical trials have established their multiple cardiovascular benefits. Several studies demonstrated that SGLT2i might reduce AF/atrial flutter events among patients with diabetes. Our cohort study and meta-analysis demonstrated a lower risk of AF recurrence with the use of SGLT2i among patients with diabetes after AF ablation. However, the beneficial effects of SGLT2i in patients after AF catheter ablation without current indications for SGLT2i were uncertain. In this study, we aim to evaluate the effect of dapagliflozin on AF burden. Patients with persistent AF undergoing initial catheter ablation without diabetes at high cardiovascular risk, heart failure, or chronic kidney disease will be enrolled. Patients will be randomly assigned to either the dapagliflozin group (10mg/d) for 3 months or the control group stratified according to body mass index (<24, ≥24kg/m2) or left atrial diameter (<45，≥45mm). The primary outcome is atrial fibrillation burden calculated as the percentage of of all atrial arrhythmia episodes detected by 7-day single-lead ECG patches at 3 months after ablation. Quality of life and echocardiography changes of left atrial structure will also be evaluated at 3 months. Our central hypothesis is that SGLT2i will reduce the AF burden after catheter ablation. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06433479
Study type	Interventional
Source	Beijing Anzhen Hospital
Contact	Chao Jiang, MD
Phone	+86 (010) 84005361
Email	superj@zju.edu.cn
Status	Not yet recruiting
Phase	N/A
Start date	June 1, 2024
Completion date	April 1, 2026

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Efficacy of Dapagliflozin on Recurrence After Catheter Ablation for Atrial Fibrillation — DARE-AF

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms