Using flecainide to treat frequent premature ventricular contractions and related heart issues

UNIFLECA Study: Prospective Cohort Study on Flecainide's Impact on Persistent High Premature Ventricular Contraction Burden and PVC-Induced Cardiomyopathy

This study is testing if the heart medication flecainide can help adults with frequent heartbeats and related heart issues who can't or don't want to have a procedure called catheter ablation.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Athens (other)
• Locations: 6 sites (Pátrai, Achaia and 5 other locations)
• Trial ID: NCT06949748 on ClinicalTrials.gov

What this trial studies

The UNIFLECA study is an observational cohort that evaluates the efficacy, safety, and tolerability of flecainide in adults experiencing frequent idiopathic premature ventricular contractions (PVCs) and suspected PVC-induced cardiomyopathy. Participants undergo thorough cardiac evaluations, including echocardiography and cardiac MRI, to confirm the absence of structural heart disease. Flecainide is administered as monotherapy, starting at a dose of 100 mg/day and potentially increasing to 200 mg/day based on clinical response and ECG findings. This study specifically targets patients who are ineligible or unwilling to undergo catheter ablation.

Who should consider this trial

Good fit: Ideal candidates are adults with frequent idiopathic PVCs and structurally normal hearts who have declined or are ineligible for catheter ablation.

Not a fit: Patients with structural heart disease, ischemic heart disease, or significant ventricular arrhythmias are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide an effective treatment option for patients suffering from PVC-induced cardiomyopathy, potentially reversing left ventricular dysfunction.

How similar studies have performed: While the use of flecainide for PVCs is established, this specific approach in a cohort with PVC-induced cardiomyopathy is novel and has not been extensively tested in prior studies.

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

Where this trial is running

Pátrai, Achaia and 5 other locations

• Cardiology Clinic, University Hospital of Patras — Pátrai, Achaia, Greece (RECRUITING)
• 1st Cardiology Clinic, National and Kapodistrian University of Athens — Athens, Attica, Greece (RECRUITING)
• Cardilogy Clinic, University of Crete — Heraklion, Greece (RECRUITING)
• 2nd Cardiology Clinic, University of Ioannina — Ioannina, Greece (ACTIVE_NOT_RECRUITING)
• 2nd Cardiology Clinic, Aristotle University of Thessaloniki — Thessaloniki, Greece (ACTIVE_NOT_RECRUITING)
• 3rd Cardiology Clinic, Aristotle University of Thessaloniki — Thessaloniki, Greece (ACTIVE_NOT_RECRUITING)

Study contacts

• Study coordinator: Dimitrios Tsiachris, MD, PhD

Conditions: Premature Ventricular Beats, Premature Ventricular Complexes, Premature Ventricular Contraction, Arrhythmia Ventricular, Ventricular Dysfunction, Left, Ventricular Dysfunction, Cardiomyopathies, Secondary, Cardiomyopathies