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Paroxysmal Atrial FibrillationNCT05773170

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

An observational study of Paroxysmal Atrial Fibrillation and Persistent Atrial Fibrillation, run by R-Pharm at 33 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Refralon
Type of treatment
Injection or infusion
How many people
1,147 participants
Where
33 sitesRussia
Study dates
11 Nov 2022to 1 Jun 2023
Phase
Observational
Are there results?
None posted in the registry

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

Study population: Hospitalized patient cohort with paroxysmal and persistent AF and AFL who underwent chemical cardioversion with Refralon®, concentrate for solution for intravenous injection, in accordance with the patient information leaflet, the current clinical guidelines of the Ministry of Health of the Russian Federation, and the approved treatment standards for AF and AFL patients in the clinical centers.

Who may be able to join

  • Diagnosis: paroxysmal or persistent atrial fibrillation or flutter;
  • A chemical cardioversion procedure performed with Refralon® in a hospital setting.

Who cannot join

  • Congenital or acquired QT interval prolongation in the electrocardiogram (ECG) in 12 standard leads for more than 440 ms at the time of cardioversion;
  • Bradysystolic atrial fibrillation or flutter (mean heart rate < 50 bpm or pauses > 3 sec, registered on the ECG or identified by the results of 24-hour Holter ECG monitoring, except for the cases of its correction by a cardiac pacemaker at the time of cardioversion;
  • Sick sinus syndrome (sinus bradycardia, sinoatrial blockade), previously registered as associated with sinus rhythm, except for the cases of its correction with a cardiac pacemaker at the time of cardioversion;
  • Degree II - III atrioventricular blockade, two- and three-beam blockade with no cardiac pacemaker at the time of cardioversion;
  • Acute myocardial infarction period at the time of cardioversion;
  • Acute period after coronary artery bypass grafting (CABG) or other cardiac surgery (at least 7 days after CABG at the time of cardioversion);
Show all 19Show fewer
  • Decompensated or severe chronic heart failure (III-IV functional class according to New York Heart Association (NYHA) classification) at the time of cardioversion;
  • Uncontrolled bronchial asthma, severe respiratory failure at the time of cardioversion;
  • Pregnancy and breastfeeding at the time of cardioversion;
  • Administration of Class IA antiarrhythmic drugs (quinidine, hydroquinidine, disopyramide, procainamide) at the time of cardioversion;
  • Class III antiarrhythmic drugs administration at the time of cardioversion;
  • Cardiac glycosides administration at the time of cardioversion;
  • Administration of QT-prolonging drugs at the time of cardioversion;
  • Heart rate < 50 bpm, pauses > 3 seconds on the ECG or Holter ECG monitoring (HM-ECG) during wakefulness at the time of cardioversion;
  • Hyperthyroidism or decompensated hypothyroidism (thyroid stimulating hormone (TSH) < lower limit of normal or > 2 upper limits of normal) at the time of cardioversion;
  • Uncorrectable electrolyte disorders (potassium level less than 3.5 mmol/L) at the time of cardioversion;
  • Identified contraindications to the sinus rhythm restoration at the time of cardioversion;
  • Blood clots in the heart cavities or spontaneous grade III-IV echo contrast at the time of cardioversion according to transesophageal echocardiography;
  • The need for electrical cardioversion due to the patient's hemodynamic instability at the time of cardioversion.

Trial locations and contacts

33 sites in 1 country.

33 sites in 1 country

Russia33 sites

  • The Regional State Budgetary Healthcare Institution "St. Joseph Belgorod Regional Clinical Hospital"

    Belgorod, 308007

  • State budgetary Healthcare Institution "Cardiological Dispensary"

    Ivanovo, 153012

  • "First Clinical Medical Center" LLC

    Kovrov, Vladimirskaya Oblast’, 601911

  • Federal State Budgetary Institution "National Medical Research Center for Therapy and Preventive Medicine" of the Ministry of Healthсare of the Russian Federation

    Moscow, 101990

  • State Budgetary Healthcare Institution "City Clinical Hospital named after I.V. Davydovsky of Moscow Healthcare Department"

    Moscow, 109240

  • Federal State Budgetary Institution "Clinical hospital № 1" administrative Department of the President of the Russian Federation

    Moscow, 121352

  • Federal State Budget Institution "A.N. Bakulev National Medical Research Center of Cardiovascular Surgery" of the Ministry of Health of the Russian Federation

    Moscow, 121552

  • State Autonomous Healthcare Institution of the Kemerovo Region "Novokuznetsk City Clinical Hospital № 1"

    Novokuznetsk, Kemerovo Oblast, 654057

  • State Budgetary Healthcare Institution of the Novosibirsk Region "Novosibirsk Regional Clinical Cardiology Dispensary"

    Novosibirsk, 630047

  • State Budgetary Healthcare Institution of the Novosibirsk region "City Clinical Hospital № 2"

    Novosibirsk, 630051

  • Clinical Health Unit No. 9

    Omsk, 644018

  • State Budgetary Healthcare Institution of the Perm Region "Clinical Cardiological Dispensary

    Perm, 614002

  • State Budgetary Institution of the Ryazan region "Regional Clinical Cardiology Dispensary"

    Ryazan, 390026

  • St. Petersburg State Budgetary Healthcare Institution "Hospital for War Veterans"

    Saint Petersburg, 193079

  • Federal State Budgetary Institution "National Medical Research Center (NMIC) named after V. A. Almazov" Ministry of Health Russia

    Saint Petersburg, 197341

  • The Saint Petersburg State Health Care Establishment the City Hospital № 40 of the Resort District

    Saint Petersburg, 197706

  • The State Budgetary Healthcare Institution of the Samara Region "Samara Regional Clinical Cardiology Dispensary named after V.P. Polyakov"

    Samara, 443070

  • Samara City Clinical Hospital № 1 named after N.I. Pirogov

    Samara, 443096

  • State Health Care Institution "Regional Cardiology Clinic"

    Saratov, 410039

  • Tambov Regional State Budgetary Healthcare Institution "S.S. Bryukhonenko City Hospital of Michurinsk"

    Tambov, 393760

  • Cardiology Research Institute, Federal State Budgetary Scientific Institution "Tomsk National Research Medical Center of the Russian Academy of Sciences"

    Tomsk, 634012

  • State health institution City Hospital № 13 Tula (Tula regional cardiological dispensary)

    Tula, 300065

  • The State Budgetary Healthcare Institution of the Tver region "Regional Clinical Hospital"

    Tver', 170036

  • Federal State Budgetary Educational Institution of Higher Education "Bashkir State Medical University" of the Ministry for Healthcare of the Russian Federation

    Ufa, Bashkortostan Republic, 450059

  • State Budgetary Healthcare Institution of Republic of Bashkortostan "City Hospital Clinical Hospital № 21"

    Ufa, Bashkortostan Republic, 450071

  • The State Budgetary Healthcare Institution of the Vladimir Region "State Hospital № 4"

    Vladimir, 600020

  • The State Budgetary Healthcare Institution "Volgograd Regional Clinical Cardiology Center"

    Volgograd, 400008

  • Budget Healthcare Institution of the Vologda Region "Vologda Regional Clinical Hospital"

    Vologda, 160002

  • The State Healthcare Institution "Voronezh Regional Hospital № 1"

    Voronezh, 394066

  • The State Budgetary Health Care Institution of the Yaroslavl Region "Regional Clinical Hospital"

    Yaroslavl, 150062

  • State Budgetary Healthcare Institution of Sverdlovsk Region "Scientific-practical center of specialized typed of medical care "URAL INSTITUTE OF CARDIOLOGY"

    Yekaterinburg, Sverdlovsk Oblast, 620063

  • State Budgetary Healthcare Institution "Sakhalin Regional Clinical Hospital"

    Yuzhno-Sakhalinsk, 690034

  • State Budgetary Healthcare Institution of the Sakhalin region "Yuzhno-Sakhalinsk City Hospital named after F.S. Ankudinov"

    Yuzhno-Sakhalinsk, 693010

Other trials in Russia

About this study

Official title: 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®?
Read the detailed description

The registry is a retrospective multicenter observational study in patients with paroxysmal and persistent forms of AF and AFL who underwent chemical cardioversion with Refralon® in a hospital setting.

After the compliance with the inclusion criteria and the absence of exclusion criteria based on medical documentation, the patient data will be collected from medical documentation available for the analysis into a unified electronic case report form (eCRF).

Alongside the study therapy, all the patients must receive an adequate anticoagulant therapy in accordance with the current clinical guidelines of the Ministry of Health of the Russian Federation. After chemical cardioversion, patients were followed up and examined as a part of routine clinical practice. The examination data will be used for this study analysis. No additional therapeutic or diagnostic procedures are provided by the analysis protocol.

Study patient follow-up period was 24 hours from the Refralon® first dose administration.

The patients' data collection is planned for 8 months. It is planned to enroll 1500 patients with persistent and paroxysmal AF and AFL, meeting the inclusion/exclusion criteria. If necessary, it is possible to extend the registry data collection period to include the planned number of patients.

Approximately in 3 and 6 months from the registry initiation (but not earlier than after the inclusion of 150 patients into the registry), an interim collected data analysis can be performed in order to preliminary assess the Refralon® efficacy and safety data in this study, as well as to identify the potential data entry errors.

Being tested
Refralon
Keywords
pharmacological cardioversion, antiarrhythmic, intravenous administration, paroxysmal and persistent atrial fibrillation and flutter
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.

  • RefralonDrug

    Also called 4-nitro-N-[(1RS)-1-(4-fluorophenyl)-2-(1-ethylpiperidin-4-yl)ethyl]benzamide hydrochloride, Niferidyl

    1 mg/ml concentrate for solution for intravenous injection. (Prior to the administration, 2 mL of Refralon® must be diluted to 20 mL in 0.9 % sodium chloride).

Study groups in NCT05773170
Study groupRoleWhat they receive
Pharmacological cardioversion with Refralon1. Refralon® 0.1% solution administration at a dose of 10 μg/kg of body weight intravenously (IV) for 2-3 minutes; It is allowed to divide the first Refralon® bolus into two consecutive injections: the first dose administration - 5 μg/kg of body weight, if the AF/AFL persists, administer the second dose - 5 μg/kg of body weight (total dose 10 μg/kg) in 15 minutes. 2. If no effect is registered (no sinus rhythm restoration), repeat IV administration of Refralon® 0.1% solution at a dose of 10 μg/kg of body weight (total dose: 20 μg/kg of body weight) in 15 minutes; 3. If no effect is registered, repeat IV administration of Refralon® 0.1% solution at a dose of 10 μg/kg of body weight (total dose: 30 μg/kg of body weight) in 15 minutes. In case of AF/AFL recurrence after the sinus rhythm restoration (with no contraindications), it is possible to re-administer Refralon®, while the maximum total drug daily dose (from the first administration) should not exceed 30 μg/kg of body weight.
Receives: Drug: Refralon

What is being measured

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

  1. Incidence of sinus rhythm restoration

    Incidence of sinus rhythm restoration within 6 hours in patients with paroxysmal AF/AFL after the first dose of Refralon®

    Measured: up to 6 hours

  2. Incidence of sinus rhythm restoration

    Incidence of sinus rhythm restoration within 24 hours in patients with persistent AF/AFL after the first dose of Refralon®

    Measured: up to 24 hours

Secondary outcomes (3)

  1. Time from the Refralon® administration start to the sinus rhythm restoration

    Measured: from Refralon® administration to the sinus rhythm restoration, up to 24 hours

  2. Incidence of sinus rhythm maintenance

    Incidence of sinus rhythm maintenance in patients 24 hours after the first Refralon® dose

    Measured: up to 24 hours

  3. Incidence of AF/AFL sustained recurrences

    Incidence of AF/AFL sustained (for more than 30 seconds) recurrences within 24 hours after the successful cardioversion with Refralon®

    Measured: up to 24 hours

Timeline

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

  1. First posted17 Mar 2023
  2. Study start11 Nov 2022
  3. Primary completion1 Jun 2023
  4. Study completion1 Jun 2023

Resources

More details

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

Study design
Study type
Observational
Observational model
Case only
Time perspective
Retrospective
Enrolment
1,147 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05773170
Sponsor's protocol ID
CC01897112
Status last verified
Oct 2023
First submitted
6 Mar 2023
Last updated
12 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Paroxysmal Atrial Fibrillation and Persistent Atrial Fibrillation, run by R-Pharm at 33 sites 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 2 inclusion and 19 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: finished, as of the sponsor's last update on 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Incidence of sinus rhythm restoration (time frame: up to 6 hours). The study lists 2 primary outcomes in all. 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 NCT05773170.

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 12 Oct 2023.

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