Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Dronedarone

    Drug

    Dronedarone 400 mg administered orally twice daily.

  • flecainide

    Drug

    Administered orally according to standard clinical practice.

  • propafenone

    Drug

    Administered orally according to standard clinical practice.

Treatment groups

1,898 Participants
are divided into 2 treatment groups
Group A: DronedaroneExperimental treatment 1 intervention
Group B: Class Ic Antiarrhythmic DrugsActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Efficacy : Recurrence of Atrial Fibrillation

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

Time frame
From randomization up to 12 months
2

Safety : Rate of Drug Discontinuation Due to Adverse Events

Percentage of participants who permanently discontinue the assigned study drug due to any adverse event (AE) or serious adverse event (SAE).

Time frame
Up to 12 months

Secondary outcomes

1

Change in Atrial Fibrillation-Specific Quality of Life (AF-QoL)

The impact of early rhythm control on quality of life will be assessed using the Atrial Fibrillation Quality of Life (AF-QoL) questionnaire. This questionnaire includes items related to psychological, physical, and sexual activity. The total score is standardized to a scale ranging from 0 to 100, with higher scores indicating a better quality of life.

Time frame
The change in scores will be compared between enrollment (baseline) and the 12-month time point.
2

Medication Adherence

The proportion of patients who remain on the assigned study medication will be measured. Adherence will be assessed using the Proportion of Days Covered (PDC) calculation. A PDC of 80% or greater is defined as adherent.

Time frame
6 months and 12 months
3

Comparison of Atrial Fibrillation Treatment Options

To assess the rates of: (a) use of Non-vitamin K Antagonist Oral Anticoagulants (NOACs), (b) use of medical therapy (rate control and rhythm control), (c) atrial fibrillation catheter ablation, and (d) direct current cardioversion (DCCV).

Time frame
Up to 12 months
4

Incidence of Other Arrhythmias on Holter or Wearable Patch ECG

To compare the detection rate of other arrhythmias (e.g., Premature Atrial Contractions (PAC), Premature Ventricular Contractions (PVC), Atrioventricular (AV) Block, Supraventricular Tachycardia (SVT), and Ventricular Tachycardia (VT)) documented by Holter or wearable patch ECG monitoring.

Time frame
Up to 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Inha University Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: