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

Phase 2

Recruiting

• Conditions: Atrial Fibrillation; Atrial Flutter
• Interventions: Drug: 4-Nitro-N-[(1RS)-1-(4-fluorophenyl)-2-(1-ethylpiperidin-4-yl)ethyl]benzamide hydrochloride; Drug: Mannitol

• Registration Number: NCT06540352
• Lead Sponsor: National Medical Research Center for Cardiology, Ministry of Health of Russian Federation

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-03
• Status Verified: 2024-08
• Study First Submitted: 2024-08-01
• Study First Submitted QC: 2024-08-01
• Study First Posted: 2024-08-06
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-22
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 mg	4-Nitro-N-[(1RS)-1-(4-fluorophenyl)-2-(1-ethylpiperidin-4-yl)ethyl]benzamide hydrochloride	-
2 mg	4-Nitro-N-[(1RS)-1-(4-fluorophenyl)-2-(1-ethylpiperidin-4-yl)ethyl]benzamide hydrochloride	-
Placebo	Mannitol	-

Primary Outcome Measures

Name	Time	Method
Proportion of subjects in the group who were shown to maintain sinus rhythm at the end of 6 months of follow-up;	6 months

Trial Locations

Locations (1)

National Medical Research Center for Cardiology, Ministry of Health of Russian Federation Organization; 🇷🇺 Moscow, Russian Federation