Dronedarone Rhythm Intervention for Early Atrial Fibrillation

Official title

A Multicenter Prospective Study on the Efficacy, Safety, and Quality of Life Improvements of Dronedarone for Early Rhythm Control in Atrial Fibrillation

Overview

The purpose of this study is to compare two commonly used types of medicine for treating atrial fibrillation (also called AF), a condition that causes an irregular heart rhythm. This study is for adults who have been diagnosed with AF within the past year. Researchers want to find out which medicine is more effective, safer, and provides a better quality of life for patients needing to control their heart rhythm. Participants who agree to join the study will be randomly assigned (like flipping a coin) to one of two groups: Group 1: Will receive the medicine Dronedarone. Group 2: Will receive a standard medicine from the 'Class Ic' group (such as flecainide or propafenone). The study will follow participants for at least 12 months. Researchers will compare how well each medicine works to prevent AF from coming back. They will also carefully track any side effects and changes in participants' quality of life during the study.

Detailed description

This study is a prospective, multicenter, randomized, open-label trial designed to address a common clinical question in the management of recent-onset atrial fibrillation (AF). Following recent evidence supporting the benefits of an early rhythm-control strategy, both dronedarone and Class Ic antiarrhythmic drugs (AADs) are widely used. However, there is a lack of large-scale, prospective, randomized data directly comparing the efficacy, safety, and quality of life outcomes between these two treatment strategies in this specific population.

The primary objective of the DRIVE-AF study is to compare the clinical outcomes of dronedarone versus standard Class Ic AADs (flecainide or propafenone) in patients with AF diagnosed within the past year.

Approximately 1,898 participants will be enrolled at 16 centers in the Republic of Korea. Eligible participants who provide informed consent will be randomized in a 1:1 ratio to receive either dronedarone or a Class Ic AAD (investigator's choice of flecainide or propafenone).

All participants will be followed for a minimum of 12 months. Efficacy will be primarily assessed by the recurrence of atrial fibrillation. Safety endpoints, particularly the rate of drug discontinuation due to adverse events, and patient-reported outcomes, including quality of life measured by the AF-QoL questionnaire, will be systematically collected and compared between the two groups.

Interventions

• Drug Dronedarone
  Dronedarone 400 mg administered orally twice daily.
• Drug flecainide
  Administered orally according to standard clinical practice.
• Drug propafenone
  Administered orally according to standard clinical practice.

Primary outcome measures

• Efficacy : Recurrence of Atrial Fibrillation [Time frame: From randomization up to 12 months]
• Safety : Rate of Drug Discontinuation Due to Adverse Events [Time frame: Up to 12 months]

Secondary outcome measures (5)

• Change in Atrial Fibrillation-Specific Quality of Life (AF-QoL) [Time frame: The change in scores will be compared between enrollment (baseline) and the 12-month time point.]
• Medication Adherence [Time frame: 6 months and 12 months]
• Comparison of Atrial Fibrillation Treatment Options [Time frame: Up to 12 months]
• Incidence of Other Arrhythmias on Holter or Wearable Patch ECG [Time frame: Up to 12 months]
• Incidence of Major Adverse Cardiovascular Events (MACE) [Time frame: Up to 12 months]

Eligibility criteria

Inclusion criteria

• Participants who have voluntarily provided written informed consent to participate.
• Adults aged 19 years or older.
• Life expectancy of at least 1 year.
• Diagnosis of atrial fibrillation within the past 1 year.
• Participants with an indication for antiarrhythmic drug therapy (Dronedarone or Class Ic agents).

Exclusion criteria

• History of failure with prior antiarrhythmic drug therapy.
• Confirmed severe structural heart disease (e.g., heart failure with reduced ejection fraction \[LVEF <= 40%\], moderate or severe mitral stenosis, mechanical heart valve replacement, or dilated cardiomyopathy).
• Diagnosis of permanent atrial fibrillation.
• Severe renal impairment (eGFR < 30 mL/min/1.73m\^2 or on dialysis) or severe hepatic impairment (Child-Pugh class B or higher) that restricts the use of antiarrhythmic drugs.
• Known contraindications to dronedarone or Class Ic antiarrhythmic drugs.
• Participation in another clinical trial within 3 months prior to randomization.
• Participants who do not agree to refrain from participating in another clinical trial within 14 days after their participation in this study ends.
• Pregnant or breastfeeding women, or women of childbearing potential who do not agree to use effective contraception during the study.
• Any other condition that, in the opinion of the investigator, makes the participant unsuitable for study participation.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

South Korea · 16 centers

• Inha University Hospital — Incheon
• Korea University Ansan Hospital — Ansan
• Soonchunhyang University Bucheon Hospital — Bucheon-si
• Kosin University Gospel Hospital — Busan
• Soonchunhyang University Cheonan Hospital — Cheonan
• Inje University Ilsan Paik Hospital — Goyang
• NHIS Ilsan Hospital — Goyang-si
• Myongji Hospital — Goyang-si
• … and 8 more centers

Identifiers

NCT: NCT07270848 · 2025-06-013

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗