Refralon Versus Amiodarone for Cardioversion of Paroxysmal Fibrillation and Atrial Flutter

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

Trial locations and contacts

1 site in 1 country.

About this study

Official title: Prospective Randomized Study Comparing the Efficacy and Safety of Refralon and Amiodarone in Cardioversion in Patients With Paroxysmal Atrial Fibrillation and Flutter

Conditions

Atrial Fibrillation Paroxysmal

Being tested

Pharmacological cardioversion with Amiodarone, Pharmacological cardioversion with Refralon

Keywords

atrial fibrillation and flutter, paroxysmal atrial fibrillation and flutter, cardioversion AF, Amiodarone, Refralon, Niferidil, new antiarrhythmic drug, new Russian antiarrhythmic drug refralon

Medical subject headings

Atrial Fibrillation

What participants receive

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

• Pharmacological cardioversion with AmiodaroneDrug

  Also called Amiodarone

  Patients in this group will receive intravenous amiodarone according to the following scheme:

  1. administration of 5 mg/kg body weight of amiodarone diluted in 250 ml of 5% glucose solution intravenously for 20-60 minutes, depending on the tolerability of the drug.
  2. if there is no effect (recovery of SR did not occur within 60 minutes from the start of the drug administration), continue the infusion of amiodarone intravenously at a dose of 100 mg/hour until a total dose of 1200 mg is reached.

• Pharmacological cardioversion with RefralonDrug

  Also called Refralon

  Patients in this group will receive intravenous refralon according to the following scheme:

  1. the introduction of a 0.1% solution of refralon at a dose of 5 μg per 1 kg of body weight, diluted in 20 ml of saline intravenously for 2-3 minutes;
  2. in the absence of effect (SR recovery did not occur), after 15 minutes, repeated intravenous administration of a 0.1% solution of refralon at a dose of 5 μg per 1 kg of body weight (total dose of the drug 10 μg / kg of body weight);
  3. in the absence of effect (SR recovery did not occur), after 15 minutes, the next intravenous injection of a 0.1% solution of refralon at a dose of 10 μg per 1 kg of body weight (total dose of the drug 20 μg / kg of body weight);
  4. in the absence of effect (recovery of SR did not occur), after 15 minutes, repeated intravenous administration of a 0.1% solution of refralon at a dose of 10 μg per 1 kg of body weight. Thus, the maximum total dose of the drug will be 30 μg/kg of body weight.

What is being measured

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

1. Restoration of sinus rhythm

   Restoration of SR within 1 hour from the start of drug administration (refralon/amiodarone).

   Measured: 1 hour

2. Restoration of sinus rhythm

   Restoration of SR within 24 hour from the start of drug administration (refralon/amiodarone).

   Measured: 24 hours

3. Number of patients who recovered sinus rhythm after the minimum dose of refralon.

   Number of patients who recovered SR when using refralon at a dose of 5 µg/kg.

   Measured: 24 hours

4. Sinus rhythm recovery time

   The time elapsed from the start of drug administration to recovery of SR

   Measured: 24 hours

5. Recurrent AF/AFL after successful cardioversion

   Absence of sustained (more than 30 seconds) recurrences of AF/AFL within 24 hours after successful cardioversion;

   Measured: 24 hours

6. Ventricular arrhythmogenic effect

   Registration of sustained and nonsustained (3 or more QRS) ventricular tachycardia or ventricular fibrillation after administration of drug (refralon/amiodarone)

   Measured: 24 hours

7. Increased QT interval (more than 500 ms)

   The number of patients who have an increase in the QT interval (more than 500 ms) and the time during which the duration of the QT interval exceeded 500 ms.

   Measured: 24 hours

8. Bradyarrhythmias (pauses and bradycardia)

   Decrease in heart rate to less than 50bpm after administration of drug (refralon/amiodarone) during AF or after restoration of SR - the minimum heart rate, the duration of the maximum recorded pause and the time during which the heart rate was less than 50bpm will be recorded

   Measured: 24 hours

9. Arterial hypotension

   Decrease in blood pressure by more than 20 mm Hg from the initial value(if asymptomatic) after administration of drug (refralon/amiodarone) or by more than 10 mm Hg (if symptomatic)

   Measured: 24 hours

10. Any clinical manifestations

    The appearance of any clinical manifestations after administration of drug (refralon/amiodarone) that are interpreted by the doctors of the intensive care unit as a worsening of patient's clinical status.

    Measured: 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 posted6 Jul 2022
2. Study start26 Jan 2022
3. Primary completion30 Jun 2023
4. Study completion30 Jun 2023

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Atrial Fibrillation ParoxysmalStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

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