Effect of Prolonged Use of Dronedarone on Recurrence in Patients With Non-paroxysmal Atrial Fibrillation After Radiofrequency Ablation

NCT ID: NCT05655468

Last Updated: 2023-04-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 268 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-29
• Study Completion Date: 2025-11-30

Brief Summary

Recurrence rate remains high after radiofrequency ablation in patients with non-paroxysmal atrial fibrillation(AF). Prolonged use of anti-arrhythmic drugs (AAD) beyond the post-ablation blanking has been adopted as a solution but without sufficient clinical evidence. Dronedarone is an AAD valid to maintain sinus rhythm and has fewer side effect than other AAD for long-term use.We sought to investigate the effect of prolonged use of dronedarone on recurrence of non-paroxysmal AF patients beyond the post-blanking period within the first year after ablation.

Detailed Description

In this multicenter, randomized, placebo-controlled trial, patients with non-paroxysmal AF will receive dronedarone for three months after radiofrequency ablation. Eligible Patients will then be randomly divided into dronedarone and placebo groups and followed up until one year after ablation. The primary endpoint is the cumulative nonrecurrence rate post three months and within one year after ablation. 7-day Holter monitoring (ECG patch) will be scheduled at 6,9, and 12 months after ablation for evaluating AA recurrence. Secondary endpoints include dronedarone withdrawal due to side effect or intolerance of AA recurrence, time to the first recurrence, repeat ablation, electrical cardioversion, unscheduled visit ,and rehospitalization.

This trial will evaluate whether prolonged use of dronedarone effectively reduces recurrence rate after ablation in non-paroxysmal AF patients. The result of this trial will provide evidence for optimizing post-ablation anti-arrhythmic therapy.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

dronedarone

dronedarone 400mg twice a day for 9 months

Group Type: EXPERIMENTAL

Dronedarone

Intervention Type: DRUG

oral administration fed conditions

placebo

Placebo(for dronedarone ) a day for 9 months

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

strictly identical in appearance with dronedarone,oral administration fed conditions

Interventions

Dronedarone

oral administration fed conditions

Intervention Type: DRUG

Placebo

strictly identical in appearance with dronedarone,oral administration fed conditions

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Aged 18-80 years;

2. Diagnosis of non-paroxysmal AF

3. Undergoing AF ablation for the first time

Exclusion Criteria

1. Unwilling to take or intolerant to dronedarone;

2. Hypersensitivity to the drug ingredient

3. Patients with decompensated heart failure, class NYHA IV, or left ventricular ejection fraction (LVEF) ≤40%

4. Bradycardia <50 bpm

5. QTc Bazett interval ≥500ms or PR interval >280ms

6. II or III atrioventricular (AV) block or sick-sinus syndrome without permanent pacemaker

7. Diagnosed with acute coronary syndrome or treated with percutaneous coronary intervention within the last 3 months

8. Patients with structural heart disease (moderate to severe aortic or mitral valve stenosis, interventricular septal thickness >15mm, congenital heart disease)

9. Accepted cardiac surgery within the last 3 months

10. Left atrial diameter (LAD) >55 mm

11. Patients with left atrial or left auricular thrombosis

12. Patients with Hyperthyroidism

13. Severe dysfunction of liver and kidney diseases (ALT≥3ULN or eGFR<30ml/min/1.73m2)

14. Abnormal blood coagulation

15. Concomitant use of dabigatran

16. Concomitant use of drugs that prolong QTc or may induce torsades de pointes

17. Concomitant use of strong CYP3A inhibitors

18. Concomitant use of another Class IA, IC, or III AADs

19. Patients suffering from serious infection, mental illness or malignant tumors

20. Pregnancy or breast-feeding

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai East Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yang Bing

deputy director of cardiovascular department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shanghai East Hospital

Shanghai, , China

Site Status: RECRUITING

Countries

China

Facility Contacts

Bing Yang, MD

Role: primary

ybheart@163.com

+86-18117141291

References

Wu Y, Fan F, Yu J, Zhou J, Xie X, Xia G, Zhong D, Cheng D, Zhang B, Wang X, Chen Z, Wang S, Li X, Yang B. Effect of Prolonged Use of Dronedarone on Recurrence in Patients with Non-Paroxysmal Atrial Fibrillation After Radiofrequency Ablation (DORIS): Rationale and Design of a Randomized Multicenter, Double-Blinded Placebo-Controlled Trial. Cardiovasc Drugs Ther. 2024 Oct;38(5):1047-1052. doi: 10.1007/s10557-023-07460-1. Epub 2023 May 8.

Reference Type: DERIVED

PMID: 37155004 (View on PubMed)

Other Identifiers

DFLC2022011

Identifier Type: -

Identifier Source: org_study_id