Flecainide in Idiopathic Premature Ventricular Contractions and Related Cardiomyopathy

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.

NCT Number	NCT06949748
Lead Sponsor	University of Athens Collaborators: Institute for Study, Research, Education and Therapy of Vascular, Heart, Brain and Kidney Nosologies, University of Patras, University General Hospital of Heraklion, Aristotle University Of Thessaloniki, Uni-Pharma
Conditions	Premature Ventricular Beats, Premature Ventricular Complexes, Premature Ventricular Contraction (PVC), Arrhythmia Ventricular, Ventricular Dysfunction, Left, Ventricular Dysfunction, Cardiomyopathies, Secondary, Cardiomyopathies
Enrollment	300 participants
Start Date	2024-04-26
Primary Completion	2027-07-01 (estimated)
Study Completion	2027-12-01 (estimated)
Updated on ClinicalTrials.gov	2025-07-02