Condition: Premature Ventricular Beats · Premature Ventricular Complexes · Premature Ventricular Contraction (PVC) · Sponsor: University of Athens
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 alterna…
This description comes directly from the study's public registry record.
Dimitrios Tsiachris, MD, PhD · +306944849926 · dtsiachris@yahoo.com
Sotirios Kotoulas, MD, MBA · +306945012410 · soter96@icloud.com
Always discuss trial participation with your own doctor first.
| 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 |
Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.
We email about this public record only. Unsubscribe anytime with one click. Never medical advice.
This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT06949748