Clinical TrialID 7306
Refralon Versus Amiodarone for Cardioversion of Paroxysmal Fibrillation and Atrial Flutter
NCT05445297
Atrial Fibrillation Paroxysmal
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 7306
- Evidence Id
- 7306
- Core Evidence Id
- 7306
- Source Clinical Trial Id
- 7296
- Herb2 Clinical Trial Id
- HBCT007296
- Nct Id
- NCT05445297
- Title
- Refralon Versus Amiodarone for Cardioversion of Paroxysmal Fibrillation and Atrial Flutter
- Status
- Phase
- Study Result
- No
- Study Condition
- Atrial Fibrillation Paroxysmal
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
- Intervention
- DRUG: Pharmacological cardioversion with Amiodarone|DRUG: Pharmacological cardioversion with Refralon
- Intervention Allocation
- Randomized
- Intervention Model
- Parallel
- Intervention Mask
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Adult, Older_Adult
- Enrollment
- 60
- Outcome Measure
- Restoration of sinus rhythm, Restoration of SR within 1 hour from the start of drug administration (refralon/amiodarone)., 1 hour|Restoration of sinus rhythm, Restoration of SR within 24 hour from the start of drug administration (refralon/amiodarone)., 24 hours|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., 24 hours|Sinus rhythm recovery time, The time elapsed from the start of drug administration to recovery of SR, 24 hours|Recurrent AF/AFL after successful cardioversion, Absence of sustained (more than 30 seconds) recurrences of AF/AFL within 24 hours after successful cardioversion;, 24 hours|Ventricular arrhythmogenic effect, Registration of sustained and nonsustained (3 or more QRS) ventricular tachycardia or ventricular fibrillation after administration of drug (refralon/amiodarone), 24 hours|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., 24 hours|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, 24 hours|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), 24 hours|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., 24 hours
- Sponsor Collaborator
- National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
- Funded By
- OTHER_GOV
- Location
- Federal State Budgetary Institution NATIONAL MEDICAL RESEARCH CENTRE OF CARDIOLOGY NAMED AFTER ACADEMICIAN E.I.CHAZOV. of the Ministry of Health of the Russian Federation, Moscow, 121552, Russian Federation
- Other Id
- JCBY-2021-0007-275
- Start Date
- 2022-01-26
- Primary Completion Date
- 2024-01-18
- Completion Date
- 2024-03-30
- First Posted
- 2022-07-06
- Results First Posted
- Last Update Posted
- 2022-07-06
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT05445297
- Title Cn
- Title En
- Refralon Versus Amiodarone for Cardioversion of Paroxysmal Fibrillation and Atrial Flutter
- Bilingual Status
- semi_complete