Status:
RECRUITING
Flecainide in Idiopathic Premature Ventricular Contractions and Related Cardiomyopathy
Lead Sponsor:
University of Athens
Collaborating Sponsors:
Institute for Study, Research, Education and Therapy of Vascular, Heart, Brain and Kidney Nosologies
University of Patras
Conditions:
Premature Ventricular Beats
Premature Ventricular Complexes
Eligibility:
All Genders
18+ years
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 prema...
Detailed Description
The UNIFLECA study is a prospective, single-arm, non-randomized observational cohort designed to evaluate the long-term efficacy and safety of flecainide (in the form of Sanocard) in adult patients wi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 26 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06949748
Start Date
April 26 2024
End Date
December 1 2027
Last Update
July 2 2025
Active Locations (6)
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1
Cardiology Clinic, University Hospital of Patras
Pátrai, Achaia, Greece, 26504
2
1st Cardiology Clinic, National and Kapodistrian University of Athens
Athens, Attica, Greece, 11527
3
Cardilogy Clinic, University of Crete
Heraklion, Greece, 71500
4
2nd Cardiology Clinic, University of Ioannina
Ioannina, Greece, 45110