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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| 1 mg | Experimental |
| |
| 2 mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4-Nitro-N-[(1RS)-1-(4-fluorophenyl)-2-(1-ethylpiperidin-4-yl)ethyl]benzamide hydrochloride | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects in the group who were shown to maintain sinus rhythm at the end of 6 months of follow-up; | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Medical Research Center for Cardiology, Ministry of Health of Russian Federation Organization | Moscow | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38132655 | Background | 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. | |
| 38224347 |
| Label | URL |
|---|---|
| Russian registry of clinical trials record | View source |
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|
| Mannitol | Drug | Placebo in tablets |
|
| 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. |
| 38954299 | Background | 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. |
| 37470730 | Background | 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. |
| 37040036 | Background | 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. |
| 36286864 | Background | 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. |
| 29276933 | Background | 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. |
| 25823268 | Background | 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. |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001282 | Atrial Flutter |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008353 | Mannitol |
| ID | Term |
|---|---|
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
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