Amiodarone hydrochloride for Persistent atrial fibrillation

Inclusion criteria

• {"criterion_text":"- Patients aged ≥ 18 ye"}
• {"criterion_text":"- Documented persistent atrial fibrillation (≥ 7 days in duration)"}
• {"criterion_text":"- Electively referred for Electrical Cardioversion under amiodarone treatment"}
• {"criterion_text":"- Signed informed consent"}

Exclusion criteria

• {"criterion_text":"- Urgent electrical cardioversion"}
• {"criterion_text":"- Significant left ventricular hypertrophy (wall thickness ≥ 15mm)"}
• {"criterion_text":"- Hyperthyroidism or hypothyroidism"}
• {"criterion_text":"- Known hepatobiliary disease (acute hepatitis, cirrhosis...) or ALT/AST > 3 x upper limit of normal (ULN)"}
• {"criterion_text":"- Allergy, intolerance, or known hypersensitivity to study medications"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Women of childbearing potential unwilling to use contraceptive measures and breastfeeding women."}
• {"criterion_text":"- Participation in another clinical trial involving investigational drugs"}
• {"criterion_text":"- Life expectancy less than 12 months"}
• {"criterion_text":"- Rheumatic mitral stenosis of any degree or severe mitral or aortic valve dysfunction."}
• {"criterion_text":"- Atrial fibrillation post-cardiac surgery"}
• {"criterion_text":"- Previous myocardial infarction"}
• {"criterion_text":"- New York Heart Association (NYHA) Class IV heart failure"}
• {"criterion_text":"- Left ventricular ejection fraction (LVEF) <45%"}

Primary endpoints

• {"endpoint_text":"- First recurrence of AF (requires ECG) after randomization.","definition_or_measurement_approach":"Requires ECG confirmation of atrial fibrillation recurrence after randomization."}

Secondary endpoints

• {"endpoint_text":"- Assessment of adverse effects, which will be determined by specific criteria including TSH levels below 0.1 microUI/ml, TSH levels exceeding 4.2 microUI/ml, a threefold increase in AST, ALT, or GGT compared to baseline levels, a QTc interval exceeding 500 ms or any other adverse effects as per the drug technical sheet.","definition_or_measurement_approach":"Adverse events determined by specified laboratory thresholds (TSH <0.1 microUI/ml or >4.2 microUI/ml), threefold increase in AST/ALT/GGT from baseline, QTc >500 ms, and other events per product label."}
• {"endpoint_text":"- Study of polymorphisms in CYP2D6, CYP2C19, CYP1A2, CYP2C8, CYP3A4, and ABCB1.","definition_or_measurement_approach":"As stated: analysis of the listed genetic polymorphisms (specific genotyping methods not described in the available record)."}
• {"endpoint_text":"- Plasma levels of amiodarone during follow-up","definition_or_measurement_approach":"Measurement of amiodarone plasma concentrations during follow-up (specific assay/method not detailed in the available record)."}
• {"endpoint_text":"- Correlate polymorphisms, with plasma levels, safety and efficacy.","definition_or_measurement_approach":"Correlation analyses between genetic polymorphisms, plasma amiodarone levels, safety outcomes and efficacy (methods not specified in the available record)."}

Spain

Earliest CTIS Part Ii Submission Date

09-01-2025

Latest Decision Or Authorization Date

27-01-2025

Processing Time Days

18

Number Of Sites

4

Number Of Participants

312

Primary sponsor

Full Name

Fundacio Institut De Recerca De L Hospital De La Santa Creu I Sant Pau

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Spain