Multicenter, Randomized Clinical Trial to Evaluate the Cardioverter Capacity of Amiodarone Pre-electrical Cardioversion in Persistent Atrial Fibrillation
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 122
- Locations
- 4
- Primary Endpoint
- Reversal to sinus rhythm pre-electrical cardioversion
Study Overview
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:
- 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).
- Treatment impregnation with amiodarone 800 mg/day started 5 days before ECV. Estimated Time to Complete Enrollment: 13 months
Detailed Description
4.3 RISK AND BENEFITS (if any) The study will compare two peri-ECV AAD regimens of amiodarone in the range of those recommended in the technical data sheet and label (16). For this reason, the risks of participation in the study would be equivalent to those present in standard clinical practice.
- OBJECTIVES AND ENDPOINTS 5.1 OBJECTIVES: 5.1.1 Primary Objective i. To compare the efficacy of amiodarone in pre-ECV reversal to sinus rhythm in a one-month impregnation regimen versus a 5-day regimen 5.1.2 Secondary Objectives i. Identify days from initiation of pre-ECV amiodarone to reversion to SR using a mobile device paired to the mobile phone.
ii. 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 5.2 ENDPOINTS 5.2.1 Endpoint (s) for the primary objective i. Reversal to sinus rhythm pre-ECV (number of patients) 5.2.2 Endpoint (s) for the secondary objectives i. Days until reversal to sinus rhythm ii. Maintenance of sinus rhythm at 1 month after cardioversion 5.3 HYPOTHESIS:
-
In patients with persistent AF referred to ECV, a long amiodarone impregnation regimen (one month pre-CVE) would induce pharmacological cardioversion in about a fifth of patients and would be superior to a short impregnation regimen (5 days).
-
Reversal to SR induced by the administration of pre-CVE amiodarone may occur in a vulnerable period for embolic events in patients in whom OAC is initiated pre-CVE. The use of a device that monitors the ECG daily will be useful to know when the reversion to pre-CVE RS occurs.
-
The proportion of patients who maintain the SR at one month post-CVE will be similar in a long regimen vs. a short regimen of pre-CVE amiodarone.
-
STUDY DESIGN This is a multicenter randomized phase IV open clinical trial. Patients with persistent AF (≥7 days duration) electively referred for CVE will be selected. After verifying that they meet the inclusion and exclusion criteria, candidates will be invited to participate in the study. Patients will receive information about the study and those who agree to participate will sign the informed consent.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients ≥18 years old.
- •Persistent atrial fibrillation (≥ 7 days duration).
- •Referred for elective electrical cardioversion.
- •Signing of the informed consent
Exclusion Criteria
- •Need of urgent electrical cardioversion
- •Mean Heart rate <50 bpm
- •Planned ablation < 1 month after ECV.
- •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)
- •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.
Arms & Interventions
Amiodarone orally impregnation starting one month before ECV
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).
Intervention: Amiodarone (Antiarrhythmic drug) (Drug)
Amiodarone orally impregnation started 5 days before ECV
Treatment impregnation with amiodarone 800 mg/day started 5 days before ECV.
Intervention: Amiodarone (Antiarrhythmic drug) (Drug)
Outcomes
Primary Outcomes
Reversal to sinus rhythm pre-electrical cardioversion
Time Frame: From date of enrollment until the date of electrical cardioversion, up to 8 weeks
Number of patients who revert to sinus rhythm before electrical cardioversion
Secondary Outcomes
- 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)