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Flecainide in Idiopathic Premature Ventricular Contractions and Related Cardiomyopathy

Recruitingn/aAges 18 Years - anyAllUniversity of Athens
NCT06949748 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The UNIFLECA study is a prospective, single-arm, observational cohort evaluating the efficacy, safety, and tolerability of flecainide (in the form of Sanocard) in adults with frequent idiopathic premature ventricular contractions (PVCs) and suspected PVC-induced cardiomyopathy (PVCi-CMP). Frequent PVCs-defined as a burden \>5% on two separate 24-hour Holter recordings-are increasingly recognized as a cause of reversible systolic dysfunction in patients without structural heart disease. Participants undergo a comprehensive baseline evaluation including echocardiography, occasionally cardiac MRI, and coronary angiography or equivalent testing to confirm the absence of structural abnormalities. Patients are enrolled only if they are ineligible or unwilling to undergo catheter ablation, and have no contraindications to flecainide. Flecainide therapy is initiated at a starting dose of 100 m

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📋 Eligibility rules (as published)
Inclusion Criteria: * Frequent idiopathic PVCs (burden \>5% on multiple 24-hour Holter ECG recordings) * Normal cardiac structure and function on echocardiography * No late gadolinium enhancement or myocardial scar on cardiac MRI * Normal coronary angiography (excluding ischemic cardiomyopathy) * Normal serum electrolytes and renal function * Willingness to comply with follow-up schedule and drug titration Exclusion Criteria: * Structural heart disease * Ischemic heart disease (confirmed by angiography) * History of sustained ventricular arrhythmias * Left ventricular ejection fraction (LVEF) \<40% at baseline * Brugada syndrome, long QT syndrome, or other channelopathies * Contraindications to class IC agents * Use of concurrent antiarrhythmics or proarrhythmic drugs
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What it tests

  • Flecainide (monotherapy)
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Where

6 sites
Cardiology Clinic, University Hospital of Patras
Pátrai, Greece
1st Cardiology Clinic, National and Kapodistrian University of Athens
Athens, Greece
Cardilogy Clinic, University of Crete
Heraklion, Greece
2nd Cardiology Clinic, University of Ioannina
Ioannina, Greece
2nd Cardiology Clinic, Aristotle University of Thessaloniki
Thessaloniki, Greece
3rd Cardiology Clinic, Aristotle University of Thessaloniki
Thessaloniki, Greece
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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