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

NCT05773170 | Completed

• 1 other identifier: CC01897112
• Study Type: observational
• Target: 1,147
• Locations: 1 country
• Sites: 33

Brief 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. 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®?

Conditions

Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation; Atrial Flutter

Keywords

pharmacological cardioversion; antiarrhythmic; intravenous administration; paroxysmal and persistent atrial fibrillation and flutter

Outcome Measures

Primary Outcomes (2)

• 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®

  up to 6 hours

• 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®

  up to 24 hours

Secondary Outcomes (3)

• Time from the Refralon® administration start to the sinus rhythm restoration

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

• Incidence of sinus rhythm maintenance

  up to 24 hours

• Incidence of AF/AFL sustained recurrences

  up to 24 hours

Study Arms (1)

Pharmacological cardioversion with Refralon

1. 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.

Drug: Refralon

Interventions

Refralon DRUG

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).

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

Pharmacological cardioversion with Refralon

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

• 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);
• 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;

Sponsors & Collaborators

• R-Pharm: lead
• FSBI "National Medical Research Center of Cardiology named after academician E.I.Chazov" of the Ministry of Health of the Russian Federation: collaborator

Study Sites (33)

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, Russia

Location

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

Ufa, Bashkortostan Republic, 450071, Russia

Location

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

Novokuznetsk, Kemerovo Oblast, 654057, Russia

Location

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

Yekaterinburg, Sverdlovsk Oblast, 620063, Russia

Location

"First Clinical Medical Center" LLC

Kovrov, Vladimirskaya Oblast’, 601911, Russia

Location

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

Belgorod, 308007, Russia

Location

State budgetary Healthcare Institution "Cardiological Dispensary"

Ivanovo, 153012, Russia

Location

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

Moscow, 101990, Russia

Location

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

Moscow, 109240, Russia

Location

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

Moscow, 121352, Russia

Location

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, Russia

Location

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

Novosibirsk, 630047, Russia

Location

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

Novosibirsk, 630051, Russia

Location

Clinical Health Unit No. 9

Omsk, 644018, Russia

Location

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

Perm, 614002, Russia

Location

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

Ryazan, 390026, Russia

Location

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

Saint Petersburg, 193079, Russia

Location

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

Saint Petersburg, 197341, Russia

Location

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

Saint Petersburg, 197706, Russia

Location

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

Samara, 443070, Russia

Location

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

Samara, 443096, Russia

Location

State Health Care Institution "Regional Cardiology Clinic"

Saratov, 410039, Russia

Location

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

Tambov, 393760, Russia

Location

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

Tomsk, 634012, Russia

Location

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

Tula, 300065, Russia

Location

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

Tver', 170036, Russia

Location

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

Vladimir, 600020, Russia

Location

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

Volgograd, 400008, Russia

Location

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

Vologda, 160002, Russia

Location

The State Healthcare Institution "Voronezh Regional Hospital № 1"

Voronezh, 394066, Russia

Location

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

Yaroslavl, 150062, Russia

Location

State Budgetary Healthcare Institution "Sakhalin Regional Clinical Hospital"

Yuzhno-Sakhalinsk, 690034, Russia

Location

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

Yuzhno-Sakhalinsk, 693010, Russia

Location

MeSH Terms

Conditions

Atrial Fibrillation; Atrial Flutter

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mikhail Samsonov

  Chief Medical Officer, R-Pharm

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: March 17, 2023
• Study Start: November 11, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: October 12, 2023

Record last verified: 2023-10

Locations

RU (33)