Evaluation of Amiodarone Hydrochloride Efficacy in Pre-Electrical Cardioversion for Persistent Atrial Fibrillation: A Multicenter Randomized Trial

The primary objective of this multicenter randomized clinical trial is to compare the **efficacy** of **amiodarone** in pre-electrical cardioversion (pre-ECV) for the reversal to sinus rhythm in patients with persistent **atrial fibrillation**. The study evaluates two different regimens: a one-month impregnation regimen versus a 5-day regimen. This comparison is clinically relevant as it aims to determine the optimal duration of amiodarone administration to enhance the success rate of cardioversion and improve patient outcomes.

Secondary objectives include: 1) Identifying the number of days from the initiation of pre-ECV amiodarone to reversion to sinus rhythm using a mobile device paired with a mobile phone; 2) Comparing the joint efficacy in the reversion to sinus rhythm pre-ECV and in the maintenance of sinus rhythm at one month after ECV between the one-month pre-ECV amiodarone regimen and the 5-day regimen. These objectives are significant for understanding the time dynamics of amiodarone's effect and its sustained efficacy in maintaining sinus rhythm post-cardioversion.

The clinical trial involves participants diagnosed with **atrial fibrillation**, specifically those experiencing persistent atrial fibrillation lasting seven days or more. The study population includes both male and female subjects aged 18 years and older. Participants were selected based on their referral for elective electrical cardioversion and their ability to provide informed consent. The trial does not include vulnerable populations. The sponsor has not provided information regarding the total number of participants. Lifestyle considerations such as diet, physical activity, or habits are not specified in the available data.

The clinical trial is designed as a **randomized**, double-blind, controlled study to evaluate the efficacy of **amiodarone** in facilitating the reversion to sinus rhythm prior to electrical cardioversion in patients with persistent **atrial fibrillation**. The trial aims to compare a one-month impregnation regimen of amiodarone with a 5-day regimen. The study is expected to commence recruitment on September 1, 2024, and conclude by March 31, 2026. Participants will be involved in the study for a maximum treatment period of 14 days, with the primary endpoint being the efficacy of amiodarone in achieving reversion to sinus rhythm before electrical cardioversion. Secondary endpoints include the time from initiation of amiodarone to reversion to sinus rhythm and the maintenance of sinus rhythm during the month following electrical cardioversion.

Study visits will follow a structured sequence, beginning with an inclusion (screening) visit to confirm eligibility based on criteria such as age (≥18 years), duration of atrial fibrillation (≥7 days), and consent to participate. Follow-up visits will be scheduled to monitor the participants' response to treatment and any adverse events. The end-of-study visit will assess the final outcomes and gather data on the maintenance of sinus rhythm. Participants may be withdrawn from the study if they experience significant adverse effects, fail to comply with the study protocol, or withdraw consent. The trial is categorized as low-intervention, focusing on a new clinical indication for the use of amiodarone, and is not intended for pediatric populations.

The clinical trial involves the use of **amiodarone hydrochloride** as the experimental medication. The product, marketed under the name Trangorex 200 mg comprimidos, is manufactured by SANOFI-AVENTIS, S.A. The pharmaceutical form of the medication is a **tablet**, and it is administered orally. The maximum daily dose is 800 mg, with a total maximum dose of 23,800 mg over a treatment period of up to 14 days. The active substance, amiodarone hydrochloride, is of chemical origin and is classified under the ATC code C01BD01. The trial aims to evaluate the efficacy of amiodarone in pre-electrical cardioversion (ECV) for the reversal to sinus rhythm in patients with persistent atrial fibrillation.

No non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatments, are specified in the trial documentation. The study focuses solely on the administration of amiodarone hydrochloride. Participant compliance with the dosing schedule will be monitored throughout the trial to ensure adherence to the prescribed regimen. The trial does not include a pediatric formulation, and the product is not classified as an orphan drug. The trial's main objective is to compare the efficacy of a one-month impregnation regimen versus a 5-day regimen of amiodarone in achieving the desired therapeutic outcome.

The efficacy of amiodarone in the clinical trial will be assessed through both primary and secondary endpoints. The primary endpoint focuses on the **efficacy** of amiodarone in achieving reversion to sinus rhythm before electrical cardioversion in patients with persistent atrial fibrillation. Secondary endpoints include the time from the initiation of amiodarone to the reversion to sinus rhythm and the maintenance of sinus rhythm during the month following electrical cardioversion.