A Multicenter Prospective Study on the Efficacy, Safety, and Quality of Life Improvements of Dronedarone for Early Rhythm Control in Atrial Fibrillation
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 1,898
- 试验地点
- 16
- 主要终点
- Safety : Rate of Drug Discontinuation Due to Adverse Events
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
Dronedarone
Participants assigned to this arm will receive dronedarone 400 mg twice daily.
干预措施: Dronedarone (Drug)
Class Ic Antiarrhythmic Drugs
Participants assigned to this arm will receive a Class Ic antiarrhythmic drug (investigator's choice of flecainide or propafenone) according to standard clinical practice.
干预措施: flecainide (Drug)
Class Ic Antiarrhythmic Drugs
Participants assigned to this arm will receive a Class Ic antiarrhythmic drug (investigator's choice of flecainide or propafenone) according to standard clinical practice.
干预措施: propafenone (Drug)
结局指标
主要结局
Safety : Rate of Drug Discontinuation Due to Adverse Events
时间窗: Up to 12 months
Percentage of participants who permanently discontinue the assigned study drug due to any adverse event (AE) or serious adverse event (SAE).
Efficacy : Recurrence of Atrial Fibrillation
时间窗: From randomization up to 12 months
Percentage of participants who experience a recurrence of atrial fibrillation (AF), atrial flutter, or atrial tachycardia lasting 30 seconds or more, as documented by 12-lead ECG, 24-hour Holter monitoring or wearable Holter monitoring
次要结局
- Change in Atrial Fibrillation-Specific Quality of Life (AF-QoL)(The change in scores will be compared between enrollment (baseline) and the 12-month time point.)
- Medication Adherence(6 months and 12 months)
- Comparison of Atrial Fibrillation Treatment Options(Up to 12 months)
- Incidence of Other Arrhythmias on Holter or Wearable Patch ECG(Up to 12 months)
- Incidence of Major Adverse Cardiovascular Events (MACE)(Up to 12 months)
研究者
Yong-Soo Baek
Associate Professor
Inha University Hospital