Evaluation of Two Different Regimens of the Antiarrhythmic Drug Amiodarone to Maintain Normal Sinus Rhythm After Electrical Cardioversion in Patients With Persistent Atrial Fibrillation

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

About this trial

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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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged ≥ 18 years

Documented persistent atrial fibrillation (≥ 7 days in duration)

Electively referred for Electrical Cardioversion

Signed informed consent.

Disqualifiers

Urgent electrical cardioversion

Atrial fibrillation post-cardiac surgery

Previous myocardial infarction

New York Heart Association (NYHA) Class IV heart failure

Trial design

Design model

Parallel

Treatments tested in this trial

  • Amiodarone Hydrochloride 200 MG

    Drug

    Patients will receive full amiodarone daily doses: 200 mg/day

  • Amiodarone Hydrochloride 100 MG

    Drug

    Patients will receive amiodarone reduced daily doses: 100 mg/d

Treatment groups

312 Participants
are divided into 2 treatment groups
Group A: Amiodarone full dosesActive comparator 1 intervention
Group B: Amiodarone reduced dosesExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Maintenance of sinus rhythm

Number of patients mantaining sinus rhythm 12 months post electrical cardioversion

Time frame
12 months follow-up

Secondary outcomes

1

Adverse effects

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Time frame
12 months follow-up
2

Polymorphisms

Association of the different assessed polymorphisms with the primary and first secondary outcome

Time frame
12 months follow-up
3

Plasma levels

Correlation of amiodarone plasma levels during follow-up with the maintenance of sinus rhythm

Time frame
12 months follow-up

Other outcomes

1

Plasma levels - polymorphisms

Correlation of amiodarone plasma levels with polymorphisms

Time frame
12 month follow-up

Sponsors and contacts

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