Flecainide in Idiopathic Premature Ventricular Contractions and Related Cardiomyopathy
Launched by UNIVERSITY OF ATHENS · Apr 22, 2025
Trial Information
Current as of June 13, 2025
Recruiting
Keywords
ClinConnect Summary
The UNIFLECA study is investigating the use of a medication called flecainide in adults who experience frequent premature ventricular contractions (PVCs) that are not caused by any known heart problems. PVCs are extra heartbeats that can lead to symptoms like palpitations and may sometimes cause heart issues. This trial aims to see if flecainide can help reduce these extra beats and improve heart function in patients who cannot or do not want to undergo a procedure called catheter ablation. To participate, individuals need to have frequent PVCs as shown in heart monitoring tests, have normal heart structure, and be willing to follow the study schedule for check-ups and medication adjustments.
Participants in the trial will start with a low dose of flecainide, which may be gradually increased based on how they respond to the treatment and their heart's electrical activity. They will have regular follow-ups over three years, including heart monitoring and assessments of how they are feeling. The study is focused on gathering real-world data to better understand how flecainide can be used as a non-invasive treatment option for patients with PVCs. If you have frequent PVCs but healthy heart structure and function, this trial might be an option for you.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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 Criteria:
- • 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
About University Of Athens
The University of Athens, a leading institution in medical research and education, is dedicated to advancing healthcare through innovative clinical trials. With a robust infrastructure and a multidisciplinary team of experts, the university focuses on translating scientific discoveries into practical applications that benefit patient care. Its commitment to ethical standards and rigorous methodologies ensures that all trials conducted under its auspices adhere to the highest principles of research integrity. By fostering collaboration with national and international partners, the University of Athens aims to contribute significantly to the global medical community and improve health outcomes through evidence-based practices.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patras, Achaia, Greece
Athens, Attika, Greece
Heraklion, , Greece
Ioannina, , Greece
Thessaloniki, , Greece
Thessaloniki, , Greece
Patients applied
Trial Officials
Dimitrios Tsiachris, MD, PhD
Study Chair
University of Athens
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported