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New pill aims to keep heart in rhythm after AFib episode

NCT ID NCT06540352

Disease control Sponsor: National Medical Research Center for Cardiology, Ministry of Health of Russian Federation 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether a new drug called Refralon, taken as a tablet once or twice daily, can prevent atrial fibrillation or flutter from returning after normal heart rhythm has been restored. About 175 adults with persistent AFib will receive either Refralon or a placebo for 6 months. Researchers will check heart rhythm at several points to see if the drug helps maintain normal rhythm better than a dummy pill.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Refralon (a drug in tablet form)
What this could lead to
If successful, this could provide a new oral medication to help people with persistent atrial fibrillation stay in normal heart rhythm and avoid repeat episodes.
What could go wrong
This is an early phase 2 study with only 175 people, so results may not apply broadly. The drug may not work better than placebo, and side effects are still being evaluated.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

175 people

The number who actually took part.

Started

Jun 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Ages

18 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: * Persistent form of AF/AFL lasting 7 days - 1 year (including patients who have previously undergone ineffective catheter or surgical ablation of AF or AFL and patients with a pacemaker or implanted cardioverter-defibrillator (ICD)); * Basic rhythm - AF and/or AFL according to the results of 12-lead ECG at randomization (Visit 2); * Left ventricular ejection fraction (LVEF) \>40% according to the Simpson method; Exclusion Criteria: * Intake of class IA, IC and class III antiarrhythmic drugs less than 7 days (for amiodarone less than 60 days) before the study drug intake; * History of myocardial infarction or other structural heart disease; * QT prolongation over 500 ms.

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Conditions

The condition(s) this trial relates to.

atrial flutter persistent atrial fibrillation atrial fibrillation prevention target

As listed by the trial registrant

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

Atrial fibrillation Atrial flutter

Contacts and locations

Locations

  • National Medical Research Center for Cardiology, Ministry of Health of Russian Federation Organization

    Moscow, Russia

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