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

NCT07273994 · tracked via the Priya Life Science Spain tracker

Sponsor

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

Phase

Phase 4

Started

2025-11-01

Last updated

2025-12-10

Condition(s) studied

Persistent Atrial Fibrillation

Investigational drug(s) / intervention(s)

Amiodarone Hydrochloride 200 MG →Amiodarone Hydrochloride 100 MG →

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

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

Study summary

\---

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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria 1. Patients aged ≥ 18 years 2. Documented persistent atrial fibrillation (≥ 7 days in duration) 3. Electively referred for Electrical Cardioversion 4. Signed informed consent. Exclusion Criteria 1. Urgent electrical cardioversion 2. Atrial fibrillation post-cardiac surgery 3. Previous myocardial infarction 4. New York Heart Association (NYHA) Class IV heart failure 5. Left ventricular ejection fraction (LVEF) \<45% 6. Significant left ventricular hypertrophy (wall thickness ≥ 15mm) 7. Hyperthyroidism or hypothyroidism 8. Known hepatobiliary disease (acute hepatitis, cirrhosis...) or ALT/AST \> 3 x upper limit of normal (ULN) 9. Allergy, intolerance, or known hypersensitivity to study medications 10. Women of childbearing potential unwilling to use contraceptive measures and breastfeeding women. 11. Participation in another clinical trial involving investigational drugs 12. Life expectancy less than 12 months 13. Rheumatic mitral stenosis of any degree or severe mitral or aortic valve dysfunction. 14. 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. 15. Patients in whom chronic amiodarone treatment previously failed to maintain sinus rhythm 16. Patients with abnormal baseline QTc (\>450 ms in males and \>470 in females) or abnormal ECG that precludes QTc assessment 17. Patients requiring concomitant medications that have a higher risk of QTc prolongation. 18. Patient do not have a smart mobile phone or do not know how to use it adequately.

Primary outcome measure(s)

Maintenance of sinus rhythm — 12 months follow-up
Number of patients mantaining sinus rhythm 12 months post electrical cardioversion

Trial sites (1)

Facility	City	Region	Status
Hospital de la Santa Creu i Sant Pau	Barcelona	Spain	Recruiting

More Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau trials in Spain

Aut-CARE Intervention to Improve Cognitive and Emotional Functioning in Young Adults on the Autism Spectrum Recruiting

Sleep Disorders in Hypothalamic and Pituitary Damage Recruiting

Deep Brain Stimulation Recovery in Treatment-Resistant Schizophrenia Active, not recruiting

Triple-A Barcelona Study Recruiting

Afatinib in Patients With Fanconi Anemia (FA) and Advanced Head and Neck Squamous Cell Carcinoma (HNSCC) Recruiting

Other trials for the same condition

Comprehensive LEFt Atrial Appendage Occlusion With Rhythm Restoration Recruiting

Radial Ablation for the Control of Persistent Atrial Fibrillation Active, not recruiting

BaLloon-based PFA Ablation poST Approval Outcomes for PAF and PersAF Recruiting

Evaluation of the FARAFLEX Mapping and Pulsed Field Ablation System in Subjects With Atrial Fibrillation Recruiting

PLAI-AF Trial: Hybrid Endo-epicardial Partial Left Atrial Isolation vs. Endocardial Ablation in Patients With Persistent Atrial Fibrillation Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07273994 on ClinicalTrials.gov ↗ ← All trials in Spain