Efficacy of Dapagliflozin on Recurrence After Catheter Ablation for Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— DARE-AF  

Official title:

Efficacy of DApagliflozin on REcurrence After Catheter Ablation for Atrial Fibrillation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06433479
• Other study ID #: 2024-4-20610
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: April 1, 2026

Study information

• Verified date: March 2024
• Source: Beijing Anzhen Hospital
• Contact: Chao Jiang, MD
• Phone: +86 (010) 84005361
• Email: superj[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: April 1, 2026
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Recurrence

Intervention

Drug:
• Dapagliflozin 10 mg per day for 3 months after initial catheter ablation
Dapagliflozin 10 mg per day for 3 months after initial catheter ablation

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Anzhen Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Atrial fibrillation burden at 3 months after ablation	Atrial fibrillation burden is defined as the percent of time spent in atrial tachyarrhythmia (atrial fibrillation, atrial flutter, or atrial tachycardia) episodes detected by 7-day single-lead ECG patches at 3 months after ablation.	3 months
Secondary	Atrial fibrillation recurrence at 3 months after ablation	Atrial fibrillation recurrence is defined as the recurrence of any atrial tachyarrhythmia (atrial fibrillation, atrial flutter, or atrial tachycardia) lasting 30 seconds or longer detected by 7-day single-lead ECG patches at 3 months after ablation.	3 months
Secondary	Changes of quality of life at 3 months	Changes of quality of life from baseline to 3 months after ablation evaluated by the Atrial Fibrillation Effect on Quality of Life (AFEQT) questionnaire.	3 months
Secondary	Echocardiography changes of left atrial structure at 3 months	Changes in the echocardiography parameter of anteroposterior atrial diameter from baseline to 3 months after ablation.	3 months
Secondary	Atrial fibrillation burden at 1 year after ablation	Atrial fibrillation burden is defined as the percent of time spent in atrial tachyarrhythmia (atrial fibrillation, atrial flutter, or atrial tachycardia) episodes detected by 7-day single-lead ECG patches at 1 year after ablation.	1 year
Secondary	Atrial fibrillation recurrence during 1 year after ablation	Atrial fibrillation recurrence is defined as the first recurrence of any atrial tachyarrhythmia (atrial fibrillation, atrial flutter, or atrial tachycardia) lasting 30 seconds or longer detected by ECG during 1 year after ablation. In-person or telephonic follow-up visits will be scheduled at 3-, 6-, and 12-month post-procedure. At each time of follow-up, the following data will be collected: (1)7-day single-lead patch ECG and (2) symptom-triggered ECG since the last follow-up.	1 year
Secondary	Cardiovascular outcomes during 1-year follow-up	The composite endpoint of cardiovascular death or cardiovascular hospitalization during 1-year follow-up.	1 year