Clinical trial NCT05773170: Efficacy and Safety Evaluation of Refralon®, Concentrate for Solution for Intravenous Injection in Patients With Paroxysmal and Persistent Atrial Fibrillation and Flutter
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Paroxysmal Atrial Fibrillation
Persistent Atrial Fibrillation
Atrial Flutter
Keywords: pharmacological cardioversion
antiarrhythmic
intravenous administration
paroxysmal and persistent atrial fibrillation and flutter
Lead sponsor: R-Pharm
Sponsor class: INDUSTRY
Collaborators: name: FSBI "National Medical Research Center of Cardiology named after academician E.I.Chazov" of the Ministry of Health of the Russian Federation
First posted: 2023-03-17
Enrollment: 1147
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

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®?

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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;
* 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.

Primary outcomes:
measure: Incidence of sinus rhythm restoration
timeFrame: up to 6 hours
measure: Incidence of sinus rhythm restoration
timeFrame: up to 24 hours
Secondary outcomes:
measure: Time from the Refralon® administration start to the sinus rhythm restoration
timeFrame: from Refralon® administration to the sinus rhythm restoration, up to 24 hours
measure: Incidence of sinus rhythm maintenance
timeFrame: up to 24 hours
measure: Incidence of AF/AFL sustained recurrences
timeFrame: up to 24 hours
Other outcomes:
Locations:
city: Ufa
country: Russian Federation
facility: Federal State Budgetary Educational Institution of Higher Education "Bashkir State Medical University" of the Ministry for Healthcare of the Russian Federation
state: Bashkortostan Republic
city: Ufa
country: Russian Federation
facility: State Budgetary Healthcare Institution of Republic of Bashkortostan "City Hospital Clinical Hospital № 21"
state: Bashkortostan Republic
city: Novokuznetsk
country: Russian Federation
facility: State Autonomous Healthcare Institution of the Kemerovo Region "Novokuznetsk City Clinical Hospital № 1"
state: Kemerovo Region
city: Yekaterinburg
country: Russian Federation
facility: State Budgetary Healthcare Institution of Sverdlovsk Region "Scientific-practical center of specialized typed of medical care "URAL INSTITUTE OF CARDIOLOGY"
state: Sverdlovsk Region
city: Kovrov
country: Russian Federation
facility: "First Clinical Medical Center" LLC
state: Vladimir Region
city: Belgorod
country: Russian Federation
facility: The Regional State Budgetary Healthcare Institution "St. Joseph Belgorod Regional Clinical Hospital"
city: Ivanovo
country: Russian Federation
facility: State budgetary Healthcare Institution "Cardiological Dispensary"
city: Moscow
country: Russian Federation
facility: Federal State Budgetary Institution "National Medical Research Center for Therapy and Preventive Medicine" of the Ministry of Healthсare of the Russian Federation
city: Moscow
country: Russian Federation
facility: State Budgetary Healthcare Institution "City Clinical Hospital named after I.V. Davydovsky of Moscow Healthcare Department"
city: Moscow
country: Russian Federation
facility: Federal State Budgetary Institution "Clinical hospital № 1" administrative Department of the President of the Russian Federation
city: Moscow
country: Russian Federation
facility: Federal State Budget Institution "A.N. Bakulev National Medical Research Center of Cardiovascular Surgery" of the Ministry of Health of the Russian Federation
city: Novosibirsk
country: Russian Federation
facility: State Budgetary Healthcare Institution of the Novosibirsk Region "Novosibirsk Regional Clinical Cardiology Dispensary"
city: Novosibirsk
country: Russian Federation
facility: State Budgetary Healthcare Institution of the Novosibirsk region "City Clinical Hospital № 2"
city: Omsk
country: Russian Federation
facility: Clinical Health Unit No. 9
city: Perm
country: Russian Federation
facility: State Budgetary Healthcare Institution of the Perm Region "Clinical Cardiological Dispensary
city: Ryazan
country: Russian Federation
facility: State Budgetary Institution of the Ryazan region "Regional Clinical Cardiology Dispensary"
city: Samara
country: Russian Federation
facility: The State Budgetary Healthcare Institution of the Samara Region "Samara Regional Clinical Cardiology Dispensary named after V.P. Polyakov"
city: Samara
country: Russian Federation
facility: Samara City Clinical Hospital № 1 named after N.I. Pirogov
city: Saratov
country: Russian Federation
facility: State Health Care Institution "Regional Cardiology Clinic"
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg State Budgetary Healthcare Institution "Hospital for War Veterans"
city: St. Petersburg
country: Russian Federation
facility: Federal State Budgetary Institution "National Medical Research Center (NMIC) named after V. A. Almazov" Ministry of Health Russia
city: St. Petersburg
country: Russian Federation
facility: The Saint Petersburg State Health Care Establishment the City Hospital № 40 of the Resort District
city: Tambov
country: Russian Federation
facility: Tambov Regional State Budgetary Healthcare Institution "S.S. Bryukhonenko City Hospital of Michurinsk"
city: Tomsk
country: Russian Federation
facility: Cardiology Research Institute, Federal State Budgetary Scientific Institution "Tomsk National Research Medical Center of the Russian Academy of Sciences"
city: Tula
country: Russian Federation
facility: State health institution City Hospital № 13 Tula (Tula regional cardiological dispensary)
city: Tver
country: Russian Federation
facility: The State Budgetary Healthcare Institution of the Tver region "Regional Clinical Hospital"
city: Vladimir
country: Russian Federation
facility: The State Budgetary Healthcare Institution of the Vladimir Region "State Hospital № 4"
city: Volgograd
country: Russian Federation
facility: The State Budgetary Healthcare Institution "Volgograd Regional Clinical Cardiology Center"
city: Vologda
country: Russian Federation
facility: Budget Healthcare Institution of the Vologda Region "Vologda Regional Clinical Hospital"
city: Voronezh
country: Russian Federation
facility: The State Healthcare Institution "Voronezh Regional Hospital № 1"
city: Yaroslavl
country: Russian Federation
facility: The State Budgetary Health Care Institution of the Yaroslavl Region "Regional Clinical Hospital"
city: Yuzhno-Sakhalinsk
country: Russian Federation
facility: State Budgetary Healthcare Institution "Sakhalin Regional Clinical Hospital"
city: Yuzhno-Sakhalinsk
country: Russian Federation
facility: State Budgetary Healthcare Institution of the Sakhalin region "Yuzhno-Sakhalinsk City Hospital named after F.S. Ankudinov"
Study officials:
affiliation: Chief Medical Officer, R-Pharm
name: Mikhail Samsonov
role: STUDY_DIRECTOR
References: