NCT06949748 Flecainide in Idiopathic Premature Ventricular Contractions and Related Cardiomyopathy
| NCT ID | NCT06949748 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Athens |
| Condition | Premature Ventricular Beats |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2024-04-26 |
| Primary Completion | 2027-07-01 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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 mg/day and titrated up to 200 mg/day, guided by ECG findings, symptom response, and QRS duration. Regular follow-up occurs at three-month intervals over three years, with periodic 24-hour Holter monitoring and assessment of symptoms, LVEF, and adverse events. The primary outcome is the reduction in PVC burden. Secondary outcomes include improvement in LVEF, symptom relief (measured by structured questionnaires), adverse effects, and long-term treatment adherence. The study aims to generate real-world data on the non-invasive management of PVCs with flecainide and explore its role as an alternative to ablation in carefully selected patients.
Eligibility Criteria
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