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

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.

Start Date03 Jun 2024

Sponsor / Collaborator

Ministry of Health of Russian Federation

NCT05773170 / CompletedNot Applicable

Retrospective Registry for the Efficacy and Safety Evaluation of Refralon®, Concentrate for Solution for Intravenous Injection in Patients With Paroxysmal and Persistent Atrial Fibrillation and Flutter

The goal of this retrospective registry is to evaluate the efficacy and safety of Refralon®, concentrate for solution for intravenous injection, as chemical cardioversion in patients with paroxysmal and persistent atrial fibrillation and flutter in routine clinical practice. The main questions it aims to answer are:
What is the incidence of sinus rhythm restoration within 6 hours in patients with paroxysmal atrial fibrillation (AF)/atrial flutter (AFL) after the first dose of Refralon®?
What is the incidence of sinus rhythm restoration within 24 hours in patients with persistent AF/AFL after the first dose of Refralon®?

Start Date11 Nov 2022

Sponsor / Collaborator

R-Pharm JSC

NCT05456204 / RecruitingNot ApplicableIIT

Efficacy and Safety of Refralon in Patients With Recurrent Atrial Fibrillation and Atrial Flutter After Catheter Ablation.

It is planned to evaluate the efficacy and safety of the class III antiarrhythmic drug refralon as a drug for pharmacological cardioversion in patients with recurrent atrial fibrillation (AF) and atrial flutter (AFL) after catheter ablation.

Start Date15 Feb 2022

Sponsor / Collaborator

Ministry of Health of Russian Federation

100 Clinical Results associated with Niferidil

100 Translational Medicine associated with Niferidil

100 Patents (Medical) associated with Niferidil

Literatures (Medical) associated with Niferidil

01 Jul 2024·Naunyn-Schmiedeberg's Archives of Pharmacology

Characterization of hERG K+ channel inhibition by the new class III antiarrhythmic drug cavutilide

Article

Author: Nesterova, Tatiana ; Pustovit, Oksana B ; Mironov, Nikolay Yu ; Abramochkin, Denis V ; Filatova, Tatiana S

Cavutilide (niferidil, refralon) is a new class III antiarrhythmic drug which effectively terminates persistent atrial fibrillation (AF; 84.6% of patients, mean AF duration 3 months) and demonstrates low risk of torsade de pointes (1.7%). ERG channels of rapid delayed rectifier current(I_Kr) are the primary target of cavutilide, but the particular reasons of higher effectiveness and lower proarrhythmic risk in comparison with other class III I_Kr blockers are unclear. The inhibition of hERG channels expressed in CHO-K1 cells by cavutilide was studied using whole-cell patch-clamp. The present study demonstrates high sensitivity of I_hERG expressed in CHO-K1 cells to cavutilide (IC50 = 12.8 nM). Similarly to methanesulfonanilide class III agents, but unlike amiodarone and related drugs, cavutilide does not bind to hERG channels in their resting state. However, in contrast to dofetilide, cavutilide binds not only to opened, but also to inactivated channels. Moreover, at positive constantly set membrane potential (+ 60 mV) inhibition of I_hERG by 100 nM cavutilide develops faster than at 0 mV and, especially, - 30 mV (τ of inhibition was 78.8, 103, and 153 ms, respectively). Thereby, cavutilide produces I_hERG inhibition only when the cell is depolarized. During the same period of time, cavutilide produces greater block of I_hERG when the cell is depolarized with 2 Hz frequency, if compared to 0.2 Hz. We suggest that, during the limited time after injection, cavutilide produces stronger inhibition of I_Kr in fibrillating atrium than in non-fibrillating ventricle. This leads to beneficial combination of antiarrhythmic effectiveness and low proarrhythmicity of cavutilide.

01 May 2024·Bulletin of Experimental Biology and Medicine

Atypical Antiadrenergic Effect of Refralon as a Mechanism of High Antiarrhythmic Effectiveness

Article

Author: Egorov, Y V

We studied the effect of Refralon on the electrophysiological properties of the supraventricular myocardium against the background of adrenergic (epinephrine) influence in the zone of the pulmonary veins, the area where 50-90% of atrial arrhythmias is triggered. The experiments were carried out on isolated tissue preparations of Wistar rats. The multichannel microelectrode array technique was used to record action potentials simultaneously in the atrium and in the ostium and distal parts of the pulmonary veins. Epinephrine application (12-50 nM) led to depolarization of the resting potential and the conduction block in the distal part of the pulmonary veins. Refralon (30 μg/kg) restored the resting potential in the distal part of the pulmonary veins. Against the background of epinephrine, Refralon did not significantly change the duration of the action potential at 90% repolarization in comparison with control. At the same time, the comparison drug E-4031 against the background of epinephrine significantly increased the duration of action potential in the atrium and in the ostium of the pulmonary veins, and sotalol increased it only in the ostium. Neither E-4031, nor sotalol restored conduction in their distal part. Refralon has a biphasic effect under conditions of adrenergic stimulation: the fast component is responsible for stabilizing the resting potential in the pulmonary vein and reduces the dispersion of action potential duration in the atrium and pulmonary vein and is also quickly washed away, and the slow component is responsible for the increase of the action potential duration and is slowly washed away.

30 Jun 2023·Kardiologiia

Early initiation of anti-relapse antiarrhythmic therapy in patients with atrial fibrillation and flutter after pharmacological cardioversion with refralon.

Article

Author: Mironov, N Yu ; Golitsyn, S P ; Gagloeva, D A ; Zelberg, M A ; Yuricheva, Yu A ; Sokolov, S F ; Dzaurova, Kh M

Aim Evaluating the efficacy and safety of early administration of antirecurrence antiarrhythmic therapy (AAT) following restoration of sinus rhythm (SR) with refralon.Aim Evaluating the efficacy and safety of early administration of antirecurrence antiarrhythmic therapy (AAT) following restoration of sinus rhythm (SR) with refralon.Material and methods The study included 247 patients with atrial fibrillation/atrial flutter (AF/AFL) (142 men) who underwent pharmacological cardioversion (PCV) with refralon. A 4-step schedule of drug administration was used (successive intravenous infusions at doses of 5, 5, 10, and 10 µg/kg; maximum total dose was 30 µg/kg). Patients who recovered SR and had no contraindications were prescribed antirecurrence AAT in the early (≤24 h; n=101) or delayed (≥24 h; n=95) period. Lappaconitine hydrobromide, propafenone, and sotalol were administered orally as the antirecurrence therapy. The decision on the time of initiating ATT and the choice of the drug and its dose was taken by the attending physician individually. The safety criteria included a prolonged PQ interval >200 ms; second- or third-degree atrioventricular block; QRS complex duration >120 ms; QT prolongation >500 ms; and heartbeat pauses >3 s. The efficacy criteria included the absence of sustained recurrence of AF/AFL after initiation of AAT and the duration of hospitalization after PCV. Patients were followed up during the study until they were discharged from the hospital.Results SR was recovered in 229 (92.7 %) patients. In the group of early AAT initiation, a PQ duration >200 ms was observed in 8 (7.9 %) patients, whereas in the group of delayed AAT initiation, in 7 patients (7.4 %; p=1.000). A wide QRS complex >120 ms was recorded in 1 (1.1 %) patient of the delayed AAT initiation group and in none of the patients of the early AAT initiation group (p=0.485). Ventricular arrhythmogenic effects and QT prolongation >500 ms were not detected in any patient. Numbers of early AF recurrence did not differ in the groups of early and delayed AAT initiation: 6 (5.9 %) vs. 5 (5.3 %), respectively (p=1.000). Median duration of hospitalization after PCV was 4 days in the group of early AAT initiation and 5 days in the group of delayed AAT initiation (р=0.009).Conclusion Early initiation of the refralon AAT does not increase the risk of drug adverse effects and reduces the duration of stay in the hospital.

100 Deals associated with Niferidil

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Indication	Highest Phase	Country/Location	Organization	Date
Atrial Fibrillation	Phase 2	RU	Ministry of Health of Russian Federation	03 Jun 2024
Atrial Flutter	Phase 2	RU	Ministry of Health of Russian Federation	03 Jun 2024

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESC2021	Not Applicable	Atrial Fibrillation	100	Niferidil 5 Î¼g/kg	ferhmpntec(blzblikwnm) = cuhofvheyv rpjooxnspa (ftvqxrlkog )	Positive	27 Aug 2021
				Niferidil 10 Î¼g/kg	ferhmpntec(blzblikwnm) = gwenqedgnw rpjooxnspa (ftvqxrlkog )

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