Actively Recruiting

Phase 4
Age: 18Years +
All Genders
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

Led by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Updated on 2025-12-10

312

Participants Needed

1

Research Sites

126 weeks

Total Duration

On this page

Sponsors

F

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

Lead Sponsor

I

Instituto de Salud Carlos III

Collaborating Sponsor

AI-Summary

What this Trial Is About

\--- 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.

CONDITIONS

Official 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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 60 18 years
  • Documented persistent atrial fibrillation (7 days or longer)
  • Electively referred for Electrical Cardioversion
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Urgent electrical cardioversion
  • Atrial fibrillation after cardiac surgery
  • Previous myocardial infarction
  • New York Heart Association Class IV heart failure
  • Left ventricular ejection fraction below 45%
  • Significant left ventricular hypertrophy (wall thickness 15 mm or more)
  • Hyperthyroidism or hypothyroidism
  • Known liver disease or elevated liver enzymes (ALT/AST more than 3 times normal)
  • Allergy or intolerance to study medications
  • Women of childbearing potential not using contraception and breastfeeding women
  • Participation in another clinical trial with investigational drugs
  • Life expectancy under 12 months
  • Rheumatic mitral stenosis or severe valve dysfunction
  • Contraindications to amiodarone (uncontrolled thyroid issues, severe bradycardia, certain heart blocks without pacemaker, prior amiodarone lung toxicity)
  • Previous failure of chronic amiodarone to maintain sinus rhythm
  • Abnormal baseline QTc on ECG or ECG preventing QTc assessment
  • Need for other medications that increase risk of QTc prolongation
  • No smart mobile phone or inability to use it properly

AI-Screening

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Trial Site Locations

Total: 1 location

1

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain, 08025

Actively Recruiting

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Research Team

J

Jose M Guerra, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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