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.
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)
Structural heart disease
Ischemic heart disease (confirmed by angiography)
History of sustained ventricular arrhythmias
Left ventricular ejection fraction (LVEF) <40% at baseline
The study population in the UNIFLECA trial consisted of adult patients with frequent idiopathic premature ventricular contractions (PVCs), defined by a PVC burden greater than 5% on multiple 24-hour Holter monitoring. All participants had structurally normal hearts, confirmed by comprehensive imaging including echocardiography, cardiac MRI if necessary, and coronary angiography to exclude cardiomyopathy or ischemic heart disease. Eligible individuals were required to have no contraindications to flecainide therapy and no history of sustained ventricular arrhythmias, significant conduction abnormalities, or inherited channelopathies. Patients were selected based on the presence of symptoms such as palpitations or fatigue and a clinical suspicion of PVC-induced cardiomyopathy, without the use of other antiarrhythmic drugs.
Cohort
Prospective
Flecainide (monotherapy)
Drug• Medication: Flecainide acetate, administered orally. * Initial Dosing and Titration: * Patients were started on an appropriate dose based on body weight and renal function. * The typical starting dose was 100-150 mg per day, split into two doses. * Dosing was titrated as needed, depending on patient response and tolerability, under close ECG and clinical monitoring. * Monitoring Protocol: * Continuous ECG monitoring during drug initiation (especially in-hospital or via Holter). * Regular outpatient follow-up visits, including: * 12-lead ECGs * Holter monitoring * Echocardiography (to monitor LVEF and assess for reverse remodeling) * ECG parameters (QRS width, QTc interval) were closely monitored for proarrhythmic changes.
PVC Burden Reduction
Change in 24-hour Holter-measured PVC burden from baseline to 3 years. Unit of Measure: Percent (%)
Change in Left Ventricular Ejection Fraction (LVEF)
* Measured by echocardiography. * Unit: Percent (%)
Safety and tolerability of flecainide
* Incidence of adverse effects (e.g., proarrhythmia, dizziness). * Unit: Number of participants with event
Symptom improvement (Questionnaire Score)
• Structured patient-reported symptom score (palpitations, fatigue, etc.). • Unit: Score on scale (e.g., 0-10)
Treatment Adherence and Dose Adjustments
* Rate of dose changes or discontinuation due to side effects. * Unit: Number of participants
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University of Athens
Lead sponsor
Institute for Study, Research, Education and Therapy of Vascular, Heart, Brain and Kidney Nosologies
Collaborator
University of Patras
Collaborator
University General Hospital of Heraklion
Collaborator
Aristotle University Of Thessaloniki
Collaborator
Uni-Pharma
Collaborator
