Actively Recruiting
UNIFLECA Study: Prospective Cohort Study on Flecainide's Impact on Persistent High Premature Ventricular Contraction Burden and PVC-Induced Cardiomyopathy
Led by University of Athens · Updated on 2025-07-02
300
Participants Needed
6
Research Sites
21 weeks
Total Duration
On this page
Sponsors
U
University of Athens
Lead Sponsor
I
Institute for Study, Research, Education and Therapy of Vascular, Heart, Brain and Kidney Nosologies
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the long-term effects of flecainide (Sanocard) in adults with frequent idiopathic premature ventricular contractions (PVCs) and suspected PVC-induced cardiomyopathy (PVCi-CMP). This observational study focuses on patients with a high PVC burden (>5% on two separate 24-hour Holter ECGs) who have structurally normal hearts but experience symptoms and are either unwilling or ineligible for catheter ablation. The goal is to understand the safety, tolerability, and efficacy of flecainide as a non-invasive treatment alternative in this group. Participants receive flecainide starting at 100 mg per day, with doses adjusted up to 200 mg per day based on clinical response, ECG findings, and symptom relief. Beta-blockers are stopped unless used for other conditions like hypertension. Patients undergo comprehensive cardiac testing at baseline, including echocardiography, cardiac MRI, and coronary angiography or equivalent, to rule out structural heart disease. Follow-up visits occur every three months over three years, with ongoing monitoring using 12-lead ECGs, 24-hour Holter recordings, and echocardiograms. During the study, participants complete symptom questionnaires and have their left ventricular ejection fraction (LVEF) and PVC burden regularly assessed. Researchers track adverse events, treatment adherence, and any dose changes. The primary outcome is the reduction of PVC burden over three years. Secondary outcomes include improvement in LVEF, symptom relief, safety, and tolerability of flecainide. This study aims to provide real-world data to guide the management of idiopathic PVCs and related cardiomyopathy.
CONDITIONS
Brief Title
Flecainide in Idiopathic Premature Ventricular Contractions and Related Cardiomyopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Frequent idiopathic PVCs with burden greater than 5% on multiple 24-hour Holter ECG recordings
- Normal cardiac structure and function by echocardiography
- No late gadolinium enhancement or myocardial scar on cardiac MRI
- Normal coronary angiography or equivalent, excluding ischemic cardiomyopathy
- Normal serum electrolytes and renal function
- Willing to comply with follow-up and medication titration
You will not qualify if you...
- Structural heart disease
- Ischemic heart disease confirmed by angiography
- History of sustained ventricular arrhythmias
- Left ventricular ejection fraction below 40% at baseline
- Brugada syndrome, long QT syndrome, or other channelopathies
- Contraindications to class IC antiarrhythmic agents
- Use of concurrent antiarrhythmic or proarrhythmic drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to 3 years
Participants receive flecainide medication as monotherapy, starting at 100 mg per day with possible titration up to 200 mg per day based on clinical response and tolerability, under close ECG and clinical monitoring.
Regular outpatient visits every 3 months including 12-lead ECGs, 24-hour Holter monitoring, and echocardiography
Duration - Up to 3 years
Participants are monitored for long-term safety, symptom improvement, and treatment adherence through regular assessments after treatment initiation.
Regular outpatient visits every 3 months overlapping with treatment visits
Trial Site Locations
Total: 6 locations
1
Cardiology Clinic, University Hospital of Patras
Pátrai, Achaia, Greece, 26504
Actively Recruiting
2
1st Cardiology Clinic, National and Kapodistrian University of Athens
Athens, Attica, Greece, 11527
Actively Recruiting
3
Cardilogy Clinic, University of Crete
Heraklion, Greece, 71500
Actively Recruiting
4
2nd Cardiology Clinic, University of Ioannina
Ioannina, Greece, 45110
Active, Not Recruiting
5
2nd Cardiology Clinic, Aristotle University of Thessaloniki
Thessaloniki, Greece, 54124
Active, Not Recruiting
6
3rd Cardiology Clinic, Aristotle University of Thessaloniki
Thessaloniki, Greece, 54124
Active, Not Recruiting
Research Team
D
Dimitrios Tsiachris, MD, PhD
S
Sotirios Kotoulas, MD, MBA
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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