Tests amiodarone before electrical cardioversion in persistent atrial fibrillation
Compares two amiodarone schedules before heart rhythm shock treatment in adults with atrial fibrillation.
Plain-language title generated from the registry record
Registry title: Evaluation of Cardioverter Capacity of Amiodarone Pre-electrical Cardioversion in Persistent Atrial Fibrillation
Key facts
- Where
- Badalona, Barcelona, Santiago de Compostela, and Tarragona, SpainSee the 4 sites
- Phase
- Phase 4
Where in Spain
- Hospital Germans Trias i PujolBadalona, SpainTaking people
- Hospital de la Santa Creu i Sant PauBarcelona, SpainTaking people
- Complexo Hospitalario Universitario De SantiagoSantiago de Compostela, SpainTaking people
- Hospital Universitari Joan XXIII de TarragonaTarragona, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Institut Investigacio Sanitaria Pere Virgili
- Trial code
- NCT06645249EU 2023-507201-34-00
- Record updated
- 2 December 2024
- Original description
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: amiodaroneRead full original descriptionShow less
Multicenter, Randomized Clinical Trial to Evaluate the Cardioverter Capacity of Amiodarone Pre-electrical Cardioversion in Persistent Atrial Fibrillation
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. 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. Treatment impregnation with amiodarone 800 mg/day started 5 days before ECV. Estimated Time to Complete Enrollment: 13 months
Inclusion: Patients ≥18 years old; Persistent atrial fibrillation (≥ 7 days duration); Referred for elective electrical cardioversion; Signing of the informed consent.
Exclusion: Treatment with anti-arrhythmic drugs (IC, III) the last 7 days previous to inclusion (in the case of amiodarone on the 30 days previous to inclusion); Participation in another clinical trial involving investigational drugs; Mean Heart rate \<50 bpm; Atrial fibrillation post-cardiac surgery; New York Heart Association (NYHA) Class IV heart failure; History of thyroid disease (hyperthyroidism or hypothyroidism); Allergy, intolerance, or known hypersensitivity to study medication; Left ventricular ejection fraction (LVEF) ≤30%; Known hepatobiliary disease (acute hepatitis, cirrhosis...) or ALT/AST \> 3 x upper limit of normal (ULN); Need of urgent electrical cardioversion; Planned ablation \< 1 month after ECV; Women of childbearing potential unwilling to use contraceptive measures; Life expectancy less than 12 months; Rheumatic mitral stenosis of any degree or severe mitral or aortic valve dysfunction.