RecruitingPhase 2NCT06540352

A Study to Select the Dose and Evaluate the Effectiveness and Safety of the Drug Refralon®, Tablets, 1 mg for Long-term Use to Prevent Recurrence of Atrial Fibrillation/Flutter After Terminating Its Persistent Form

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Select the Dose and Evaluate the Effectiveness and Safety of the Drug Refralon®, Tablets, 1 mg (Pharmproekt JSC) for Long-term Use to Prevent Recurrence of Atrial Fibrillation/Flutter After Terminating Its Persistent Form


Sponsor

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

Enrollment

200 participants

Start Date

Jun 3, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Refralon® tablets in two different doses (1 or 2 tablets per day) will be evaluated vs. placebo in patients with persistent atrial fibrillation/flutter after synus rhythm restoration in order to prevent recurrence of arrhythmia. Efficacy and safety of Refralon® tablets will be studied, its optimal dose will be selected and its pharmacokinetics will be evaluated in 14 days, 1, 3 and 6 months.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a heart rhythm medication called Refralon at different doses to find the best long-term dose for preventing atrial fibrillation (AFib) or atrial flutter from coming back after treatment has restored a normal heart rhythm. AFib is an irregular heartbeat that can cause stroke and heart failure. **You may be eligible if...** - You have persistent AFib or atrial flutter (lasting 7 days to 1 year) - Your heart's pumping function (left ventricular ejection fraction) is above 40% - You currently have AFib or flutter on your ECG at the time of enrollment **You may NOT be eligible if...** - You have had a heart attack or other structural heart disease - Your QT interval (a heart rhythm measurement) is prolonged over 500 ms - You have taken certain antiarrhythmic drugs recently (within 7 days, or 60 days for amiodarone) - You have severe kidney or liver disease - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG4-Nitro-N-[(1RS)-1-(4-fluorophenyl)-2-(1-ethylpiperidin-4-yl)ethyl]benzamide hydrochloride

The drug Refralon® (n-1-\[(4-fluorophenyl)-2-(1-ethyl-4-piperidyl)-ethyl\]-4-nitrobenzamide hydrochloride) in the dosage form of a concentrate for the preparation of a solution for intravenous administration is registered for medical use in RF June 24, 2014, re-registration was successfully completed on November 20, 2019, registration certificate LP 002510, until December 31, 2025.

DRUGMannitol

Placebo in tablets


Locations(1)

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

Moscow, Russia

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NCT06540352


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