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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: dtsiachris@yahoo.com
• Phone: +306944849926

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• RHYthm and Myocardial Function Relationship in Heart Disease

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  Recruiting Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Roma · NCT07491237

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.