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NCT Number: NCT07273994

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

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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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location status: Recruiting

Location contact

Jose M Guerra, MD, PhD

CONTACT

[email protected]

+34 935565945

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged ≥ 18 years
  • Documented persistent atrial fibrillation (≥ 7 days in duration)
  • Electively referred for Electrical Cardioversion
  • Signed informed consent.

Exclusion criteria

  • Urgent electrical cardioversion
  • Atrial fibrillation post-cardiac surgery
  • Previous myocardial infarction
  • New York Heart Association (NYHA) Class IV heart failure
  • Left ventricular ejection fraction (LVEF) <45%
  • Significant left ventricular hypertrophy (wall thickness ≥ 15mm)
  • 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 medications
  • Women of childbearing potential unwilling to use contraceptive measures and breastfeeding women.
  • 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.
  • Patients with contraindications to amiodarone, such as uncontrolled thyroid dysfunction, severe sinus bradycardia, second- or third-degree AV block without a pacemaker, and a history of amiodarone-induced pulmonary toxicity.
  • Patients in whom chronic amiodarone treatment previously failed to maintain sinus rhythm
  • Patients with abnormal baseline QTc (>450 ms in males and >470 in females) or abnormal ECG that precludes QTc assessment
  • Patients requiring concomitant medications that have a higher risk of QTc prolongation.
  • Patient do not have a smart mobile phone or do not know how to use it adequately.

Treatment and study plan

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

Primary outcomes

  1. Maintenance of sinus rhythm

    Time frame: 12 months follow-up

    Number of patients mantaining sinus rhythm 12 months post electrical cardioversion

Secondary outcomes

  1. Adverse effects

    Time frame: 12 months follow-up

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

  2. Polymorphisms

    Time frame: 12 months follow-up

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

  3. Plasma levels

    Time frame: 12 months follow-up

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

Other outcomes

  1. Plasma levels - polymorphisms

    Time frame: 12 month follow-up

    Correlation of amiodarone plasma levels with polymorphisms

Study contacts

Contact information is provided by the study sponsor or research team.

Jose M Guerra, MD, PhD

CONTACT

[email protected]

+34 935565945

Sponsors and collaborators

Lead sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Other

Collaborators

  • Instituto de Salud Carlos III

Registry information

Official study title

Multicenter Randomized Clinical Trial To Evaluate Two Different Amiodarone Regimens To Maintain Sinus Rhythm After Electrical Cardioversion In Persistent Atrial Fibrillation

Acronym: PERIVERSION-2

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Dec 10, 2025
Registry last updated
Dec 10, 2025

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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