Trials Sponsors Conditions Drugs Pricing

Conditions

Atrial Flutter Paroxysmal Atrial Fibrillation Persistent Atrial Fibrillation

Keywords

pharmacological cardioversionantiarrhythmicintravenous administrationparoxysmal 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

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

RefralonDrug

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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:

Sponsors & Collaborators

FSBI "National Medical Research Center of Cardiology named after academician E.I.Chazov" of the Ministry of Health of the Russian Federation
Type not reportedcollaborator
R-Pharm
Industrylead

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

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

Ufa, Bashkortostan Republic, 450071, Russia

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

Novokuznetsk, Kemerovo Oblast, 654057, Russia

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

"First Clinical Medical Center" LLC

Kovrov, Vladimirskaya Oblast’, 601911, Russia

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

MeSH Terms

Conditions

Atrial FibrillationAtrial Flutter

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

Mikhail Samsonov
Chief Medical Officer, R-Pharm
STUDY DIRECTOR

Enrollment

1,147 participants (actual enrollment reported by the registry).

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

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Study Arms (1)

Pharmacological cardioversion with Refralon

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (33)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Study Arms (1)

Pharmacological cardioversion with Refralon

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (33)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations