Comparative Efficacy of 100-, 200-, & 400-mg Amiodarone in Patients With Paroxysmal AF Depending on Plasma Concentration

NCT07487714 | Enrolling By Invitation Phase 4

• 1 other identifier: CRI-281
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Amiodarone is a highly effective drug for the treatment and prevention of arrhythmias. In the 1970s and 1980s, numerous experimental and clinical studies comprehensively examined the mechanisms of amiodarone's antiarrhythmic action, as well as its effectiveness in various types of arrhythmias. This explains why drug therapy is so widespread today. According to the CAMIAT study, which included 1,202 patients with ventricular extrasystole who had suffered a myocardial infarction, amiodarone administration reduced the risk of arrhythmic death by 48.5%, and by 35% in the EMIAT study. In the GESICA study, amiodarone therapy was documented to reduce overall mortality by 45%, the incidence of sudden cardiac death by 54%, and mortality from progressive heart failure by 40%. In Russia, amiodarone is prescribed as a first-line drug for AF in 41% of cases with organic myocardial disease, in 52% as a second-line drug, and in 12.5% in the absence of organic heart damage. Moreover, the effectiveness of maintaining sinus rhythm in atrial fibrillation varies from 30 to 95.2%, which is a significant range when predicting the effectiveness of treatment. Attempts to assess amiodarone concentrations during therapy and to analyze the correlation with the achieved effects have been made repeatedly. While assessing amiodarone concentrations is generally considered inappropriate, based on the results of numerous studies, the use of monitoring is justified in certain clinical situations where the desired clinical effect or adverse events are absent. A detailed analysis of systemic reviews revealed significant shortcomings in the formation of such judgments. The groups were heterogeneous, small in number, and included, among other things, individual clinical situations and different routes of drug administration. A literature review did not reveal any data on the analysis of the concentration of amiodarone and desethylamiodarone as an anti-relapse therapy for atrial fibrillation when used consistently in doses acceptable by clinical guidelines with the possibility of titration under laboratory monitoring.

Conditions

Paroxysmal AF; Treatment Decisions; Therapeutic Drug Monitoring (TDM)

Keywords

High performance liquid chromatography; amiodarone; desethylamiodarone; atrial fibrillation

Outcome Measures

Primary Outcomes (1)

• Incidence of of patients with recurrent atrial fibrillation paroxysms (percentage)

  The primary endpoint is an incidence (percentage) of patients with recurrent atrial fibrillation paroxysms during amiodarone therapy after reaching a steady-state saturation concentration of amiodarone and desethylamiodarone. Median saturation time is 16 days. After reaching saturation concentration of amiodarone in plasma, patients are followed up for three months.

  106 days

Secondary Outcomes (8)

• Heart rate (bpm)

  106 days

• Incidence (percentage) of patients with prolongation of the QT interval up to 500 ms and more

  106 days

• Duration of the QT interval (ms)

  106 days

• Rate of second-degree atrioventricular conduction blocks on the ECG and 24-hour ECG (persantage)

  106 days

• Rate of third-degree atrioventricular conduction blocks on the ECG and 24-hour ECG (persantage)

  106 days

Study Arms (3)

Treatment with Amoidarone at a dose 200 mg per day

ACTIVE COMPARATOR

Patients in this group are treated with amiodarone at a dose 200 mg per day for three months

Drug: Pharmacotherapy with amiodarone 200 mg per day

Treatment with Amiodarone at a dose 100 mg per day

ACTIVE COMPARATOR

Patients in this group are treated with amiodarone at a dose 100 mg per day for three months in case of sufficient clinical efficacy of this dose or in case of adverse drug reactions to 200-mg amiodarone administered at higher dose before.

Drug: Treatment with Amiodarone at a dose 100 mg per day

Treatment with Amiodarone at a dose 400 mg per day

ACTIVE COMPARATOR

Patients in this group are treated with amiodarone at a dose 400 mg per day for three months in case of insufficient clinical efficacy and in the absence of adverse drug reactions to 200 mg.

Drug: Treatment with Amiodarone at a dose 400 mg per day

Interventions

Pharmacotherapy with amiodarone 200 mg per day DRUG

Patients are treated with amiodarone at a dose of 200 mg per day.

Also known as: Amiodarone 200 mg

Treatment with Amoidarone at a dose 200 mg per day

Treatment with Amiodarone at a dose 100 mg per day DRUG

Patients are treated with amiodarone at a dose of 100 mg per day.

Also known as: Amiodarone 100 mg

Treatment with Amiodarone at a dose 100 mg per day

Treatment with Amiodarone at a dose 400 mg per day DRUG

Patients are treated with amiodarone at a dose of 400 mg per day.

Also known as: Amiodarone 400 mg

Treatment with Amiodarone at a dose 400 mg per day

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient must have a documented electrocardiogram (ECG) or 24-hour ECG monitoring for paroxysmal AF.
• Patient age \>18 years.
• Signed informed consent for participation in the study.
• Indications for amiodarone.

You may not qualify if:

• Contraindications to the administration of amiodarone according to the drug's instructions for use
• Patients with coronary artery disease with confirmed ischemia based on stress tests and the need for revascularization based on coronary angiography and multispiral computed tomography coronary angiography.
• Patients with resistant arterial hypertension.
• Planned catheter treatment of atrial fibrillation during the follow up period or early within 3 months postoperative period for catheter treatment of atrial fibrillation.
• Thrombosis of the heart cavities.
• Concomitant therapy with psychotropic drugs, antiarrhythmics of class IA and III, antibiotics, antifungal drugs, antimalarial and antiprotozoal drugs, antitumor, antiemetic drugs and drugs affecting gastrointestinal motility, antihistamines;
• Patients incapacitated due to psychoneurological conditions;
• Pregnant women or women of childbearing age planning pregnancy during the study.

Sponsors & Collaborators

• Tomsk National Research Medical Center of the Russian Academy of Sciences: lead

Study Sites (1)

Kievskaya street 111a Cardiology research institute

Tomsk, 634012, Russia

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Drug Therapy; Amiodarone; Therapeutics

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Roman E Batalov, MD, PhD

  Cardiology Research Institute of Tomsk NRMC

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 23, 2026
• Study Start: January 12, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Proposals may be submitted up to 36 months following publication of the results of the trial. After 36 months, the data will be available in the Center's data ware house but without investigator support other than deposited metadata.
• Access Criteria: Information

Locations

RU (1)