Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 11:38 PM
Study NCT ID:
NCT07273994
Status:
RECRUITING
Last Update Posted:
2025-12-10
First Post:
2025-03-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Two Different Regimens of the Antiarrhythmic Drug Amiodarone to Maintain Normal Sinus Rhythm After Electrical Cardioversion in Patients With Persistent Atrial Fibrillation
Sponsor:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Organization:
Study Overview
Official Title:
Multicenter Randomized Clinical Trial To Evaluate Two Different Amiodarone Regimens To Maintain Sinus Rhythm After Electrical Cardioversion In Persistent Atrial Fibrillation
Status:
RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PERIVERSION-2
Brief Summary:
\---
The goal of this clinical trial is to learn if reduced doses of amiodarone can treat atrial fibrillation (AF) effectively while minimizing toxic side effects in patients with persistent AF after electrical cardioversion. The main questions it aims to answer are:
* Can a reduced dose of amiodarone (100 mg/day) maintain sinus rhythm as effectively as the standard dose (200 mg/day) 12 months post electrical cardioversion?
* What are the adverse effects of the standard and reduced doses of amiodarone during 12 months post electrical cardioversion?
* How do genetic polymorphisms affect the efficacy and safety of amiodarone?
* How do amiodarone plasma levels correlate with the maintenance of sinus rhythm and genetic polymorphisms?
Researchers will compare the standard dose (200 mg/day) to the reduced dose (100 mg/day) to see if the reduced dose offers a better balance between efficacy and safety.
Participants will:
* Be treated with full dose amiodarone (200 mg/day) during the first month after electrical cardioversion.
* Be randomized to either continue with the full dose (200 mg/day) or switch to the reduced dose (100 mg/day).
The study is a multicenter, randomized clinical trial involving 312 patients with persistent AF after successful electrical cardioversion. Participants will be followed for 12-18 months to monitor the recurrence of AF and adverse effects.
The goal of this clinical trial is to learn if reduced doses of amiodarone can treat atrial fibrillation (AF) effectively while minimizing toxic side effects in patients with persistent AF after electrical cardioversion. The main questions it aims to answer are:
* Can a reduced dose of amiodarone (100 mg/day) maintain sinus rhythm as effectively as the standard dose (200 mg/day) 12 months post electrical cardioversion?
* What are the adverse effects of the standard and reduced doses of amiodarone during 12 months post electrical cardioversion?
* How do genetic polymorphisms affect the efficacy and safety of amiodarone?
* How do amiodarone plasma levels correlate with the maintenance of sinus rhythm and genetic polymorphisms?
Researchers will compare the standard dose (200 mg/day) to the reduced dose (100 mg/day) to see if the reduced dose offers a better balance between efficacy and safety.
Participants will:
* Be treated with full dose amiodarone (200 mg/day) during the first month after electrical cardioversion.
* Be randomized to either continue with the full dose (200 mg/day) or switch to the reduced dose (100 mg/day).
The study is a multicenter, randomized clinical trial involving 312 patients with persistent AF after successful electrical cardioversion. Participants will be followed for 12-18 months to monitor the recurrence of AF and adverse effects.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: