Dronedarone Rhythm Intervention for Early Atrial Fibrillation
ConditionAtrial Fibrillation (AF)
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age19+
SponsorInha University Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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/1.73m² or on dialysis) or severe hepatic impairment (Child-Pugh class B or higher) that restricts the use of antiarrhythmic drugs.
Trial design
Treatments tested in this trial
- Dronedarone
- flecainide
- propafenone
Treatment groups
1,898 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov