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New treatment option for Persistent Atrial Fibrillation
Official title Evaluation of Two Different Regimens of the Antiarrhythmic Drug Amiodarone to Maintain Normal Sinus Rhythm After Electrical Cardioversion in Patients With Persistent Atrial Fibrillation
ClinicalTrials.gov ID: NCT07273994
What this study is testing
What is Amiodarone Hydrochloride 200 MG?
Amiodarone Hydrochloride 200 MG is an investigational medicine, given as an once-daily, being studied as a potential treatment for persistent atrial fibrillation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- \--- 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?
- Phase 4: studies an already-approved treatment
- Time commitment: about 12 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients aged ≥ 18 years
- Documented persistent atrial fibrillation (≥ 7 days in duration)
- Electively referred for Electrical Cardioversion
- Signed informed consent.
You likely can't join 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)
See the full eligibility criteria
- Patients aged ≥ 18 years
- Documented persistent atrial fibrillation (≥ 7 days in duration)
- Electively referred for Electrical Cardioversion
- Signed informed consent.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Barcelona, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Barcelona, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.