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 | Recruiting Phase 4 DMC

• 3 other identifiers: IIBSP-AMI-2024-33Project PI023/17682024-514113-35-00
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Persistent Atrial Fibrillation

Keywords

Atrial fibrillation; Electrical cardioversion; Amiodarone; Pharmacogenetics; Adverse effects

Outcome Measures

Primary Outcomes (1)

• Maintenance of sinus rhythm

  Number of patients mantaining sinus rhythm 12 months post electrical cardioversion

  12 months follow-up

Secondary Outcomes (3)

• Adverse effects

  12 months follow-up

• Polymorphisms

  12 months follow-up

• Plasma levels

  12 months follow-up

Other Outcomes (1)

• Plasma levels - polymorphisms

  12 month follow-up

Study Arms (2)

Amiodarone full doses

ACTIVE COMPARATOR

Patients will receive amiodarone full doses (200 mg/day) (Usual dose)

Drug: Amiodarone Hydrochloride 200 MG

Amiodarone reduced doses

EXPERIMENTAL

Patients will receive amiodarone reduced doses (100 mg/day)

Drug: Amiodarone Hydrochloride 100 MG

Interventions

Amiodarone Hydrochloride 200 MG DRUG

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

Amiodarone full doses

Amiodarone Hydrochloride 100 MG DRUG

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

Amiodarone reduced doses

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead
• Instituto de Salud Carlos III: collaborator

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Amiodarone

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Jose M Guerra, MD, PhD

CONTACT

+34 935565945; jguerra@santpau.cat

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: December 10, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: December 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)