UNIFLECA Study Evaluating Flecainide for Adults with Frequent Idiopathic Premature Ventricular Contractions and Suspected Cardiomyopathy

What this Trial Is About

Researchers are evaluating the long-term effects of flecainide Sanocard in adults with frequent idiopathic premature ventricular contractions PVCs and suspected PVC-induced cardiomyopathy PVCi-CMP. This observational study focuses on patients with a high PVC burden >5% on two separate 24-hour Holter ECGs who have structurally normal hearts but experience symptoms and are either unwilling or ineligible for catheter ablation. The goal is to understand the safety, tolerability, and efficacy of flecainide as a non-invasive treatment alternative in this group. Participants receive flecainide starting at 100 mg per day, with doses adjusted up to 200 mg per day based on clinical response, ECG findings, and symptom relief. Beta-blockers are stopped unless used for other conditions like hypertension. Patients undergo comprehensive cardiac testing at baseline, including echocardiography, cardiac MRI, and coronary angiography or equivalent, to rule out structural heart disease. Follow-up visits occur every three months over three years, with ongoing monitoring using 12-lead ECGs, 24-hour Holter recordings, and echocardiograms. During the study, participants complete symptom questionnaires and have their left ventricular ejection fraction LVEF and PVC burden regularly assessed. Researchers track adverse events, treatment adherence, and any dose changes. The primary outcome is the reduction of PVC burden over three years. Secondary outcomes include improvement in LVEF, symptom relief, safety, and tolerability of flecainide. This study aims to provide real-world data to guide the management of idiopathic PVCs and related cardiomyopathy.

Flecainide in Idiopathic Premature Ventricular Contractions and Related Cardiomyopathy