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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Greece
1st Cardiology Clinic, National and Kapodistrian University of Athens
RECRUITING
Athens
Cardilogy Clinic, University of Crete
RECRUITING
Heraklion
2nd Cardiology Clinic, University of Ioannina
ACTIVE_NOT_RECRUITING
Ioannina
Cardiology Clinic, University Hospital of Patras
RECRUITING
Pátrai
2nd Cardiology Clinic, Aristotle University of Thessaloniki
ACTIVE_NOT_RECRUITING
Thessaloniki
3rd Cardiology Clinic, Aristotle University of Thessaloniki
ACTIVE_NOT_RECRUITING
Thessaloniki
Contact Information
Primary
Dimitrios Tsiachris, MD, PhD
dtsiachris@yahoo.com
+306944849926
Backup
Sotirios Kotoulas, MD, MBA
soter96@icloud.com
+306945012410
Time Frame
Start Date: 2024-04-26
Estimated Completion Date: 2027-12-01
Participants
Target number of participants: 300
Treatments
High PVC Burden Cohort
Persistent, high PVC Burden (\>5%) in 24h Holter Monitoring
Sponsors
Collaborators: University of Crete Medical School - University Hospital of Heraklion, Aristotle University Of Thessaloniki, Uni-Pharma, Institute for Study, Research, Education and Therapy of Vascular, Heart, Brain and Kidney Nosologies, University of Patras
Leads: University of Athens

This content was sourced from clinicaltrials.gov