Evaluation of Two Different Regimens of the Antiarrhythmi... | NCT07273994

Studies
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

Sponsor

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

Status

Recruiting

Last Update Posted

Dec 10, 2025Actual

Enrollment

312Estimated

Phase

Phase 4

Conditions

Persistent Atrial Fibrillation

Interventions

Amiodarone Hydrochloride 200 MG
Amiodarone Hydrochloride 100 MG

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
Project PI023/1768	Other Grant/Funding Number	Instituto Salud Carlos III, Ministry of Science, Innovation and Universities, Government of Spain.
2024-514113-35-00	EU Trial (CTIS) Number

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2025Actual

Primary Completion Date

Dec 2027Estimated

Completion Date

Apr 2028Estimated

First Submitted Date

Mar 19, 2025

First Submission Date that Met QC Criteria

Dec 9, 2025

First Posted Date

Dec 10, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 9, 2025

Last Update Posted Date

Dec 10, 2025Actual

Name	Class
Instituto de Salud Carlos III	OTHER_GOV

Description Module

Brief Summary

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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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

312Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Amiodarone Hydrochloride 200 MG	Drug	Patients will receive full amiodarone daily doses: 200 mg/day	Amiodarone full doses

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maintenance of sinus rhythm	Number of patients mantaining sinus rhythm 12 months post electrical cardioversion	12 months follow-up

Secondary Outcomes

Measure	Description	Time Frame
Adverse effects	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	12 months follow-up
Polymorphisms	Association of the different assessed polymorphisms with the primary and first secondary outcome

Other Outcomes

Measure	Description	Time Frame
Plasma levels - polymorphisms	Correlation of amiodarone plasma levels with polymorphisms	12 month follow-up

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D001572	Benzofurans
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds