Dronedarone Rhythm Intervention for Early Atrial Fibrillation

NCT07270848 | Not Yet Recruiting Phase 4

• 1 other identifier: 2025-06-013
• Study Type: interventional
• Target: 1,898
• Locations: 1 country
• Sites: 16

Brief Summary

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.

Conditions

Atrial Fibrillation (AF)

Keywords

Atrial Fibrillation; Dronedarone; Flecainide; Propafenone; Antiarrhythmic Drugs; Rhythm Control

Outcome Measures

Primary Outcomes (2)

• 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

  From randomization up to 12 months

• 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).

  Up to 12 months

Secondary Outcomes (5)

• 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

Study Arms (2)

Dronedarone

EXPERIMENTAL

Participants assigned to this arm will receive dronedarone 400 mg twice daily.

Drug: Dronedarone

Class Ic Antiarrhythmic Drugs

ACTIVE COMPARATOR

Participants assigned to this arm will receive a Class Ic antiarrhythmic drug (investigator's choice of flecainide or propafenone) according to standard clinical practice.

Drug: flecainide; Drug: propafenone

Interventions

flecainide DRUG

Administered orally according to standard clinical practice.

Also known as: Tambocor

Class Ic Antiarrhythmic Drugs

propafenone DRUG

Administered orally according to standard clinical practice.

Also known as: Rytmonorm

Class Ic Antiarrhythmic Drugs

Dronedarone DRUG

Dronedarone 400 mg administered orally twice daily.

Also known as: Multaq, Drone Tab.

Dronedarone

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Inha University Hospital: lead

Study Sites (16)

Inha University Hospital

Incheon, Incheon, 22332, South Korea

Location

Korea University Ansan Hospital

Ansan, 15355, South Korea

Location

Soonchunhyang University Bucheon Hospital

Bucheon-si, 14584, South Korea

Location

Kosin University Gospel Hospital

Busan, 49267, South Korea

Location

Soonchunhyang University Cheonan Hospital

Cheonan, 31151, South Korea

Location

Inje University Ilsan Paik Hospital

Goyang, 10380, South Korea

Location

NHIS Ilsan Hospital

Goyang-si, 10444, South Korea

Location

Myongji Hospital

Goyang-si, 10475, South Korea

Location

Hanyang University Guri Hospital

Guri-si, 11923, South Korea

Location

Jeju National University Hospital

Jeju City, 63241, South Korea

Location

Sejong Chungnam National University Hospital

Sejong, 30099, South Korea

Location

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

Severance Hospital

Seoul, 03722, South Korea

Location

Ewha Womans University Seoul Hospital

Seoul, 07804, South Korea

Location

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

Wonju Severance Christian Hospital

Wŏnju, 26426, South Korea

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Dronedarone; Unmanned Aerial Devices; Flecainide; Propafenone

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amiodarone; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Aircraft; Aviation; Transportation; Technology, Industry, and Agriculture; Piperidines; Heterocyclic Compounds, 1-Ring; Propiophenones; Ketones; Organic Chemicals

Study Officials

• Yong-Soo Baek, M.D., Ph.D.

  Division of Cardiology, Department of Internal Medicine, Inha University College of Medicine and Inha University Hospital, Incheon, Republic of Korea.

  STUDY CHAIR

Central Study Contacts

Yong-Soo Baek, M.D., Ph.D.

CONTACT

+82-32-890-2200; existsoo@inha.ac.kr

Hyoung Seok Lee, M.D.

CONTACT

+82-32-890-3575; hyoungseok_lee@inha.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 8, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (16)