NCT07273994RecruitingPhase 4
Evaluation of Two Different Regimens of the Antiarrhythmic Drug Amiodarone to Maintain Normal Sinus Rhythm After Electrical Cardioversion in Patients With Persistent Atrial Fibrillation
Multicenter Randomized Clinical Trial To Evaluate Two Different Amiodarone Regimens To Maintain Sinus Rhythm After Electrical Cardioversion In Persistent Atrial Fibrillation
Source: ClinicalTrials.gov · Last updated 10 Dec 2025
Brief summary (registry, in English)
\--- 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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 312 (estimated)
- First submitted
- 19 Mar 2025
- Start date
- 1 Nov 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Diseases
- Atrial fibrillation
- NCT number
- NCT07273994
- EU CT number
- 2024-514113-35-01
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 312
- From 1 Nov 2025 to the primary completion date, 31 Dec 2027
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous myocardial infarction
- Participation in another clinical trial involving investigational drugs
- Patients in whom chronic amiodarone treatment previously failed to maintain sinus rhythm
Other illness
- Atrial fibrillation post-cardiac surgery
- New York Heart Association (NYHA) Class IV heart failure
- Allergy, intolerance, or known hypersensitivity to study medications
- 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.
Lab values
- Left ventricular ejection fraction (LVEF) \<45%
- Known hepatobiliary disease (acute hepatitis, cirrhosis...) or ALT/AST \> 3 x upper limit of normal (ULN)
- 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.
Other
- Urgent electrical cardioversion
- Significant left ventricular hypertrophy (wall thickness ≥ 15mm)
- Hyperthyroidism or hypothyroidism
- Women of childbearing potential unwilling to use contraceptive measures and breastfeeding women.
- Life expectancy less than 12 months
- Rheumatic mitral stenosis of any degree or severe mitral or aortic valve dysfunction.
- Patient do not have a smart mobile phone or do not know how to use it adequately.
Who the study is looking for
- Patients aged ≥ 18 years
- Documented persistent atrial fibrillation (≥ 7 days in duration)
- Electively referred for Electrical Cardioversion
- Signed informed consent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Germans Trias i Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Recruiting |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Salut Sant Joan de Reus Coordinator of this site? Confirm its status | Reus | Spain | Recruiting |
| Complexo Hospitalario Universitario De Santiago Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.