Flecainide in Idiopathic Premature Ventricular Contractions and Related Cardiomyopathy

NCT06949748 | Recruiting DMC FDA Drug

• 1 other identifier: 8014/25-04-2024
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 6

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.

Conditions

Premature Ventricular Beats; Premature Ventricular Complexes; Premature Ventricular Contraction (PVC); Arrhythmia Ventricular; Ventricular Dysfunction, Left; Ventricular Dysfunction; Cardiomyopathies, Secondary; Cardiomyopathies

Keywords

Flecainide; Sanocard; UNIFLECA; PVC induced CMP; PVC; Premature Ventricular Contraction; Outflow Tract PVC; NonOutflow Tract PVC

Outcome Measures

Primary Outcomes (1)

• PVC Burden Reduction

  Change in 24-hour Holter-measured PVC burden from baseline to 3 years. Unit of Measure: Percent (%)

  3 years

Secondary Outcomes (4)

• Change in Left Ventricular Ejection Fraction (LVEF)

  3 years

• Safety and tolerability of flecainide

  3 years

• Symptom improvement (Questionnaire Score)

  3 years

• Treatment Adherence and Dose Adjustments

  3 years

Study Arms (1)

High PVC Burden Cohort

Persistent, high PVC Burden (\>5%) in 24h Holter Monitoring

Drug: Flecainide (monotherapy)

Interventions

Flecainide (monotherapy) DRUG

• Medication: Flecainide acetate, administered orally. * Initial Dosing and Titration: * Patients were started on an appropriate dose based on body weight and renal function. * The typical starting dose was 100-150 mg per day, split into two doses. * Dosing was titrated as needed, depending on patient response and tolerability, under close ECG and clinical monitoring. * Monitoring Protocol: * Continuous ECG monitoring during drug initiation (especially in-hospital or via Holter). * Regular outpatient follow-up visits, including: * 12-lead ECGs * Holter monitoring * Echocardiography (to monitor LVEF and assess for reverse remodeling) * ECG parameters (QRS width, QTc interval) were closely monitored for proarrhythmic changes.

High PVC Burden Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population in the UNIFLECA trial consisted of adult patients with frequent idiopathic premature ventricular contractions (PVCs), defined by a PVC burden greater than 5% on multiple 24-hour Holter monitoring. All participants had structurally normal hearts, confirmed by comprehensive imaging including echocardiography, cardiac MRI if necessary, and coronary angiography to exclude cardiomyopathy or ischemic heart disease. Eligible individuals were required to have no contraindications to flecainide therapy and no history of sustained ventricular arrhythmias, significant conduction abnormalities, or inherited channelopathies. Patients were selected based on the presence of symptoms such as palpitations or fatigue and a clinical suspicion of PVC-induced cardiomyopathy, without the use of other antiarrhythmic drugs.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Athens: lead
• Institute for Study, Research, Education and Therapy of Vascular, Heart, Brain and Kidney Nosologies: collaborator
• University of Patras: collaborator
• University of Crete Medical School - University Hospital of Heraklion: collaborator
• Aristotle University Of Thessaloniki: collaborator
• Uni-Pharma: collaborator

Study Sites (6)

Cardiology Clinic, University Hospital of Patras

Pátrai, Achaia, 26504, Greece

RECRUITING

1st Cardiology Clinic, National and Kapodistrian University of Athens

Athens, Attica, 11527, Greece

RECRUITING

Cardilogy Clinic, University of Crete

Heraklion, 71500, Greece

RECRUITING

2nd Cardiology Clinic, University of Ioannina

Ioannina, 45110, Greece

ACTIVE NOT RECRUITING

2nd Cardiology Clinic, Aristotle University of Thessaloniki

Thessaloniki, 54124, Greece

ACTIVE NOT RECRUITING

3rd Cardiology Clinic, Aristotle University of Thessaloniki

Thessaloniki, 54124, Greece

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Ventricular Premature Complexes; Ventricular Dysfunction, Left; Ventricular Dysfunction; Cardiomyopathies

Interventions

Flecainide

Condition Hierarchy (Ancestors)

Cardiac Complexes, Premature; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Dimitrios Tsiachris, MD, PhD

  University of Athens

  STUDY CHAIR

Central Study Contacts

Dimitrios Tsiachris, MD, PhD

CONTACT

+306944849926; dtsiachris@yahoo.com

Sotirios Kotoulas, MD, MBA

CONTACT

+306945012410; soter96@icloud.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Assistant Professor of Cardiology

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: April 29, 2025
• Study Start: April 26, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

GR (6)