Evaluation of Cardioverter Capacity of Amiodarone Pre-electrical Cardioversion in Persistent Atrial Fibrillation

NCT06645249 | Not Yet Recruiting Phase 4 DMC

• 3 other identifiers: 2023-507201-34-00SCC 2023SEC/FEC-INV-CLI 23/24
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 4

Brief Summary

Phase: IV Population: Sample size= 122 patients; male and female; ≥ 18 y.o.; patients with persistent atrial fibrillation referred for electrical cardioversion; performed in Spain Number of Sites: 4 Study Duration: 15/10/2024 - 15/5/2026 Subject Participation Duration: 2-4 months (depending on the arm) Description of Agent or Intervention: amiodarone Objectives: Primary: To compare the efficacy of amiodarone in pre-ECV reversal to sinus rhythm in a one-month impregnation regimen versus a 5-day regimen Secondary: 1) Identify days from initiation of pre-ECV amiodarone to reversion to SR using a mobile device paired to the mobile phone; 2) To compare the joint efficacy in the reversion to SR pre-ECV and in the maintenance of SR at 1 month after ECV of a one-month pre-ECV amiodarone impregnation regimen vs a 5-day regimen Description of Study Design: Multicenter randomized open clinical trial. 122 Patients with persistent AF (≥7 days duration) electively referred for CVE will be included. Two amiodarone regimens administered pre-CVE will be compared evaluating their cardioverter efficacy. Patients will be randomized to 2 groups:

1. 1.Treatment impregnation with amiodarone starting one month before ECV (600 mg/day 1st week, 400 mg/day 2nd week and 200 mg/day thereafter until ECV).
2. 2.Treatment impregnation with amiodarone 800 mg/day started 5 days before ECV. Estimated Time to Complete Enrollment: 13 months

Conditions

Atrial Fibrillation (AF)

Keywords

Atrial fibrillation; Electrical cardioversion; amiodarone; Pharmacological cardioversion

Outcome Measures

Primary Outcomes (1)

• Reversal to sinus rhythm pre-electrical cardioversion

  Number of patients who revert to sinus rhythm before electrical cardioversion

  From date of enrollment until the date of electrical cardioversion, up to 8 weeks

Secondary Outcomes (2)

• Days until reversal to sinus rhythm

  From date of enrollment until date of electrical cardioversion, up to 8 weeks

• Maintenance of sinus rhythm at 1 month after cardioversion

  From date of reversion to sinus rhythm until 1 month later

Study Arms (2)

Amiodarone orally impregnation starting one month before ECV

EXPERIMENTAL

Treatment impregnation with amiodarone starting one month before ECV (600 mg/day 1st week, 400 mg/day 2nd week and 200 mg/day thereafter until ECV).

Drug: Amiodarone (Antiarrhythmic drug)

Amiodarone orally impregnation started 5 days before ECV

ACTIVE COMPARATOR

Treatment impregnation with amiodarone 800 mg/day started 5 days before ECV.

Drug: Amiodarone (Antiarrhythmic drug)

Interventions

Amiodarone (Antiarrhythmic drug) DRUG

Comparing 2 regimes of amiodarone pre-electrical cardioversion witn ECG monitoring

Amiodarone orally impregnation started 5 days before ECV; Amiodarone orally impregnation starting one month before ECV

Eligibility Criteria

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

You may qualify if:

• Patients ≥18 years old.
• Persistent atrial fibrillation (≥ 7 days duration).
• Referred for elective electrical cardioversion.
• Signing of the informed consent

You may not qualify if:

• Need of urgent electrical cardioversion
• Mean Heart rate \<50 bpm
• Planned ablation \< 1 month after ECV.
• Atrial fibrillation post-cardiac surgery
• New York Heart Association (NYHA) Class IV heart failure
• Left ventricular ejection fraction (LVEF) ≤30%
• History of thyroid disease (hyperthyroidism or hypothyroidism)
• Known hepatobiliary disease (acute hepatitis, cirrhosis...) or ALT/AST \> 3 x upper limit of normal (ULN)
• Allergy, intolerance, or known hypersensitivity to study medication
• Women of childbearing potential unwilling to use contraceptive measures
• Participation in another clinical trial involving investigational drugs
• Life expectancy less than 12 months
• Rheumatic mitral stenosis of any degree or severe mitral or aortic valve dysfunction.

Sponsors & Collaborators

• Institut Investigacio Sanitaria Pere Virgili: lead
• Spanish Society of Cardiology: collaborator
• Sociedad Espanola de Cardiologia: collaborator

Study Sites (4)

Hospital Universitari Germans Trias i Pujol

Badalona, 08916, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

Hospital Universitari de Sant Joan

Reus, 43204, Spain

Location

Hospital Clínico Universitario de Santiago

Santiago de Compostela, 15706, Spain

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Amiodarone; Anti-Arrhythmia Agents

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; Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Josep M. Alegret, MD, PhD

CONTACT

+34 689952316; josepmaria.alegret@urv.cat

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a multicenter randomized phase IV open clinical trial. Patients with persistent AF (≥7 days duration) electively referred for CVE will be selected. Two amiodarone regimens administered pre-CVE will be compared evaluating their cardioverter efficacy. Patients will be randomized to 2 groups: c. Treatment impregnation with amiodarone starting one month before ECV (600 mg/day 1st week, 400 mg/day 2nd week and 200 mg/day thereafter until ECV). d.Treatment impregnation with amiodarone 800 mg/day started 5 days before ECV.

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 16, 2024
• Study Start: December 10, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

ES (4)