Lower versus standard amiodarone dose to keep normal heart rhythm after electrical cardioversion

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with persistent atrial fibrillation who undergo elective electrical cardioversion will be treated with either 200 mg/day or 100 mg/day of amiodarone and followed for 12 months. The trial compares maintenance of sinus rhythm at 12 months and records adverse events during follow-up. Researchers will measure amiodarone plasma levels and analyze genetic polymorphisms to see how genetics relate to drug levels, effectiveness, and toxicity. Regular clinical visits and laboratory testing will monitor rhythm status and safety.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hospital de la Santa Creu i Sant Pau
  Barcelona, Spain Recruiting

Study contacts

• Study coordinator: Jose M Guerra, MD, PhD
• Email: jguerra@santpau.cat
• Phone: +34 935565945

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.