Hospital de la Santa Creu i Sant Pau
Barcelona, 08025, Spain
Location status: Recruiting
NCT Number: NCT07273994
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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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 4
Barcelona, 08025, Spain
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will receive full amiodarone daily doses: 200 mg/day
Patients will receive amiodarone reduced daily doses: 100 mg/d
Time frame: 12 months follow-up
Number of patients mantaining sinus rhythm 12 months post electrical cardioversion
Time frame: 12 months follow-up
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 12 months follow-up
Association of the different assessed polymorphisms with the primary and first secondary outcome
Time frame: 12 months follow-up
Correlation of amiodarone plasma levels during follow-up with the maintenance of sinus rhythm
Time frame: 12 month follow-up
Correlation of amiodarone plasma levels with polymorphisms
Contact information is provided by the study sponsor or research team.
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Other
Multicenter Randomized Clinical Trial To Evaluate Two Different Amiodarone Regimens To Maintain Sinus Rhythm After Electrical Cardioversion In Persistent Atrial Fibrillation
Acronym: PERIVERSION-2
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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