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New study pits dronedarone against standard drugs for AF control

NCT ID NCT07270848

Disease control Sponsor: Inha University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two types of medicine for atrial fibrillation (AF), a condition causing irregular heartbeat. About 1,900 adults diagnosed with AF in the past year will be randomly assigned to take either dronedarone or a standard Class Ic drug (like flecainide). Researchers will track which medicine better prevents AF from returning, monitor side effects, and measure changes in quality of life over at least 12 months.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 1,898 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

atrial fibrillation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atrial fibrillation (AF)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    16 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Ewha Womans University Seoul Hospital

    Seoul, 07804, South Korea

  • Hanyang University Guri Hospital

    Guri-si, 11923, South Korea

  • Inha University Hospital

    Incheon, Incheon, 22332, South Korea

  • Inje University Ilsan Paik Hospital

    Goyang, 10380, South Korea

  • Jeju National University Hospital

    Jeju City, 63241, South Korea

  • Korea University Anam Hospital

    Seoul, 02841, South Korea

  • Korea University Ansan Hospital

    Ansan, 15355, South Korea

  • Korea University Guro Hospital

    Seoul, 08308, South Korea

  • Kosin University Gospel Hospital

    Busan, 49267, South Korea

  • Myongji Hospital

    Goyang-si, 10475, South Korea

  • NHIS Ilsan Hospital

    Goyang-si, 10444, South Korea

  • Sejong Chungnam National University Hospital

    Sejong, 30099, South Korea

  • Severance Hospital

    Seoul, 03722, South Korea

  • Soonchunhyang University Bucheon Hospital

    Bucheon-si, 14584, South Korea

  • Soonchunhyang University Cheonan Hospital

    Cheonan, 31151, South Korea

  • Wonju Severance Christian Hospital

    Wŏnju, 26426, South Korea

More trials for these conditions

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