Flecainide in Idiopathic Premature Ventricular Contractions and Related Cardiomyopathy

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.

Conditions

• Premature Ventricular Beats
• Premature Ventricular Complexes
• Premature Ventricular Contraction (PVC)
• Arrhythmia Ventricular
• Ventricular Dysfunction, Left
• Ventricular Dysfunction
• Cardiomyopathies, Secondary
• Cardiomyopathies

Interventions

DRUG

Flecainide (monotherapy)

• 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.

Sponsors & Collaborators

• Institute for Study, Research, Education and Therapy of Vascular, Heart, Brain and Kidney Nosologies

  collaborator UNKNOWN

• University of Patras

  collaborator OTHER

• University of Crete Medical School - University Hospital of Heraklion

  collaborator UNKNOWN

• Aristotle University Of Thessaloniki

  collaborator OTHER

• Uni-Pharma

  collaborator INDUSTRY

• University of Athens

  lead OTHER

Principal Investigators

• Dimitrios Tsiachris, MD, PhD · University of Athens

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-04-26

Primary Completion

2027-07-01

Completion

2027-12-01

FDA Drug

Yes

Countries

• Greece

Study Locations