NCT06949748 Flecainide in Idiopathic Premature Ventricular Contractions and Related Cardiomyopathy
| NCT ID | NCT06949748 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Athens |
| Condition | Premature Ventricular Beats |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2024-04-26 |
| Primary Completion | 2027-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2024-04-26 with a primary completion date of 2027-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 alternative to ablation in carefully selected patients.
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
Contact & Investigator
Dimitrios Tsiachris, MD, PhD
STUDY CHAIR
University of Athens
Frequently Asked Questions
Who can join the NCT06949748 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Premature Ventricular Beats. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06949748 currently recruiting?
Yes, NCT06949748 is actively recruiting participants. Contact the research team at dtsiachris@yahoo.com for enrollment information.
Where is the NCT06949748 trial being conducted?
This trial is being conducted at Pátrai, Greece, Athens, Greece, Heraklion, Greece, Ioannina, Greece and 2 additional locations.
Who is sponsoring the NCT06949748 clinical trial?
NCT06949748 is sponsored by University of Athens. The principal investigator is Dimitrios Tsiachris, MD, PhD at University of Athens. The trial plans to enroll 300 participants.