Clinical trial NCT06540352: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Atrial Fibrillation
Atrial Flutter
Keywords: Refralon
Cavutilide
Niferidil
class III antiarrhythmic drug
new Russian drug
atrial fibrillation (AF)
tablet
atrial flutter (AFL)
Lead sponsor: National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
Sponsor class: OTHER_GOV
First posted: 2024-08-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of subjects in the group who were shown to maintain sinus rhythm at the end of 6 months of follow-up;
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: National Medical Research Center for Cardiology, Ministry of Health of Russian Federation Organization
Study officials:
References:
citation: Beliaeva MM, Dzaurova KM, Yuricheva YA, Novikov PS, Mironov NY, Tarasovskiy GS, Zelberg MA, Sokolov SF, Golitsyn SP. Intravenous Cavutilide for Pharmacological Conversion of Paroxysmal and Persistent Atrial Fibrillation in Patients with Heart Failure. J Cardiovasc Dev Dis. 2023 Dec 6;10(12):487. doi: 10.3390/jcdd10120487.
citation: Abramochkin DV, Pustovit OB, Mironov NY, Filatova TS, Nesterova T. Characterization of hERG K+ channel inhibition by the new class III antiarrhythmic drug cavutilide. Naunyn Schmiedebergs Arch Pharmacol. 2024 Jul;397(7):5093-5104. doi: 10.1007/s00210-023-02940-5. Epub 2024 Jan 15.
citation: Egorov YV. Atypical Antiadrenergic Effect of Refralon as a Mechanism of High Antiarrhythmic Effectiveness. Bull Exp Biol Med. 2024 May;177(1):57-62. doi: 10.1007/s10517-024-06131-x. Epub 2024 Jul 2.
citation: Gagloeva DA, Dzaurova KM, Zelberg MA, Mironov NY, Yuricheva YA, Sokolov SF, Golitsyn SP. Early initiation of anti-relapse antiarrhythmic therapy in patients with atrial fibrillation and flutter after pharmacological cardioversion with refralon. Kardiologiia. 2023 Jun 30;63(6):21-27. doi: 10.18087/cardio.2023.6.n2276. English, Russian.
citation: Abramochkin DV, Pustovit OB, Mironov NY, Filatova TS, Kuzmin VS. The Dependence of the Electrophysiological Effects of Class III Antiarrhythmic Drug Refralon on the Frequency of Myocardium Activation. Bull Exp Biol Med. 2023 Mar;174(5):610-615. doi: 10.1007/s10517-023-05756-8. Epub 2023 Apr 11.
citation: Dzaurova KM, Mironov NY, Yuricheva YA, Vlodzyanovsky VV, Mironova NA, Laiovich LY, Malkina TA, Zinchenko LV, Sokolov SF, Golitsyn SP. [Efficiency and safety of using the modified protocol for the administration of the domestic class III antiarrhythmic drug for the relief of paroxysmal atrial fibrillation]. Ter Arkh. 2021 Sep 15;93(9):1052-1057. doi: 10.26442/00403660.2021.09.201008. Russian.
citation: Golitsyn SP, Saidova MA, Sokolov SF, Vlodzyanovskiy VV, Malkina TA, Rozenshtraukh LV, Chazov EI. [Restoration of Sinus Rhythm in Patients With Persistent Atrial Fibrillation and Obesity: New Possibilities of Pharmacological Cardioversion]. Kardiologiia. 2017 Oct;57(10):80-86. doi: 10.18087/cardio.2017.10.10036. Russian.
citation: Maykov EB, Yuricheva YA, Mironov NY, Sokolov SF, Golitsyn SP, Rozenshtraukh LV, Chazov EI. [Refralon (niferidil) is a new class III antiarrhythmic agent for pharmacological cardioversion for persistent atrial fibrillation and atrial flutter]. Ter Arkh. 2015;87(1):38-48. doi: 10.17116/terarkh201587138-48. Russian.