AzTrials
AzTrials

Atrial FibrillationPhase 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 Phase 2 study testing 4-Nitro-N-[(1RS)-1-(4-fluorophenyl)-2-(1-ethylpiperidin-4-yl)ethyl]benzamide hydrochloride and Mannitol in people with Atrial Fibrillation and Atrial Flutter, run by National Medical Research Center for Cardiology, Ministry of Health of Russian Federation at 1 site in Russia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation, Atrial Flutter
What is being tested?
4-Nitro-N-[(1RS)-1-(4-fluorophenyl)-2-(1-ethylpiperidin-4-yl)ethyl]benzamide hydrochloride and Mannitol
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
175 participants
Where
1 siteRussia
Study dates
3 Jun 2024to 31 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Russia1 site

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

    Moscow

Other trials in Russia

About this study

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

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.

Being tested
4-Nitro-N-[(1RS)-1-(4-fluorophenyl)-2-(1-ethylpiperidin-4-yl)ethyl]benzamide hydrochloride, Mannitol
Keywords
Refralon, Cavutilide, Niferidil, class III antiarrhythmic drug, new Russian drug, atrial fibrillation (AF), tablet, atrial flutter (AFL)
Medical subject headings
Atrial Fibrillation, Atrial Flutter

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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.

  • MannitolDrug

    Placebo in tablets

Study groups in NCT06540352
Study groupRoleWhat they receive
PlaceboPlacebo comparatorNot described
Receives: Drug: Mannitol
1 mgExperimentalNot described
Receives: Drug: 4-Nitro-N-[(1RS)-1-(4-fluorophenyl)-2-(1-ethylpiperidin-4-yl)ethyl]benzamide hydrochloride
2 mgExperimentalNot described
Receives: Drug: 4-Nitro-N-[(1RS)-1-(4-fluorophenyl)-2-(1-ethylpiperidin-4-yl)ethyl]benzamide hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2024
  2. Study start3 Jun 2024
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
175 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06540352
Sponsor's protocol ID
REF-II-08-2023
Status last verified
Apr 2026
First submitted
1 Aug 2024
Last updated
8 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38132655

  • 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.

    PubMed 38224347

  • 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.

    PubMed 38954299

  • 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.

    PubMed 37470730

  • 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.

    PubMed 37040036

  • 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.

    PubMed 36286864

  • 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.

    PubMed 29276933

  • 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.

    PubMed 25823268

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 4-Nitro-N-[(1RS)-1-(4-fluorophenyl)-2-(1-ethylpiperidin-4-yl)ethyl]benzamide hydrochloride and Mannitol in people with Atrial Fibrillation and Atrial Flutter, run by National Medical Research Center for Cardiology, Ministry of Health of Russian Federation at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of subjects in the group who were shown to maintain sinus rhythm at the end of 6 months of follow-up; (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06540352, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.

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