Premature Ventricular BeatsUNIFLECANCT06949748
Flecainide in Idiopathic Premature Ventricular Contractions and Related Cardiomyopathy
An observational study of Premature Ventricular Beats and Premature Ventricular Complexes, run by University of Athens at 6 sites in Greece.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Premature Ventricular Beats, Premature Ventricular Complexes, Premature Ventricular Contraction (PVC)
- What is being tested?
- Flecainide (monotherapy)
- Type of treatment
- Pill or oral medicine
- How many people
- 300 participants
- Where
- 6 sitesGreece
- Study dates
- 26 Apr 2024to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Greece6 sites, 3 recruiting
- Recruiting
1st Cardiology Clinic, National and Kapodistrian University of Athens
Athens, Attica, 11527
Dimitrios Tsiachris, MD, PhD, +306944849926, dtsiachris@yahoo.com
Sotirios Kotoulas, MD, MBA
- Recruiting
Cardilogy Clinic, University of Crete
Heraklion, 71500
Eleftherios Kallergis, MD, PhD, +306941509898, eleftherioskallergis@gmail.com
- Active, not recruiting
2nd Cardiology Clinic, University of Ioannina
Ioannina, 45110
- Recruiting
Cardiology Clinic, University Hospital of Patras
Pátrai, Achaia, 26504
- Active, not recruiting
2nd Cardiology Clinic, Aristotle University of Thessaloniki
Thessaloniki, 54124
- Active, not recruiting
3rd Cardiology Clinic, Aristotle University of Thessaloniki
Thessaloniki, 54124
About this study
Official title: UNIFLECA Study: Prospective Cohort Study on Flecainide's Impact on Persistent High Premature Ventricular Contraction Burden and PVC-Induced Cardiomyopathy
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.
Read more
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.
Read the detailed description
The UNIFLECA study is a prospective, single-arm, non-randomized observational cohort designed to evaluate the long-term efficacy and safety of flecainide (in the form of Sanocard) in adult patients with frequent idiopathic premature ventricular contractions (PVCs) and suspected PVC-induced cardiomyopathy (PVCi-CMP). Despite being considered benign in structurally normal hearts, a persistently high PVC burden-particularly above 10%-is increasingly recognized as a cause of reversible left ventricular dysfunction and a potential trigger for cardiomyopathy. This condition is frequently underdiagnosed and may lead to unnecessary treatments or delayed intervention.
The study targets a unique population: symptomatic patients with idiopathic PVCs who have structurally normal hearts and have either declined catheter ablation or are ineligible for invasive procedures. Each patient undergoes comprehensive baseline cardiac evaluation, including transthoracic echocardiography, cardiac magnetic resonance imaging (CMR) to exclude late gadolinium enhancement or myocardial scar, and coronary angiography or non-invasive equivalent to rule out ischemic heart disease. Two 24-hour Holter ECG recordings, taken at least 30 days apart, are used to confirm persistent high PVC burden (>5%).
Flecainide, a Class IC antiarrhythmic agent with sodium channel-blocking properties, is administered as monotherapy. The initial dose is 100 mg/day and may be titrated up to 200 mg/day based on clinical response, patient tolerability, and QRS interval monitoring. Beta-blockers are discontinued unless used for unrelated comorbidities such as hypertension. Patients are monitored with serial 12-lead ECGs, Holter recordings, and echocardiograms at baseline and every three months over a total follow-up period of three years.
The primary endpoint is the percentage reduction in PVC burden as measured by 24-hour Holter ECG. Secondary endpoints include (1) improvement in left ventricular ejection fraction (LVEF), (2) symptom relief as assessed by structured patient questionnaires focusing on palpitations, bradysphygmia, fatigue, dizziness, and exercise intolerance, (3) incidence of adverse events including proarrhythmia, conduction disturbances, and neurological side effects, and (4) adherence to long-term flecainide therapy, including need for dose modifications or drug discontinuation.
This investigator-initiated study is being conducted across tertiary arrhythmia centers in Greece. It aims to fill a significant evidence gap in the long-term pharmacologic management of idiopathic PVCs and PVCi-CMP. Preliminary results indicate significant PVC burden reduction and symptomatic improvement, supporting the potential utility of flecainide as an effective non-invasive therapeutic option in appropriately selected patients. Data from this study will contribute to optimizing treatment strategies for idiopathic ventricular arrhythmias in the absence of structural heart disease, supporting the use of personalized medicine and risk stratification.
- Conditions
- Premature Ventricular Beats, Premature Ventricular Complexes, Premature Ventricular Contraction (PVC), Arrhythmia Ventricular, Ventricular Dysfunction, Left, Ventricular Dysfunction
- Being tested
- Flecainide (monotherapy)
- Keywords
- Flecainide, Sanocard, UNIFLECA, PVC induced CMP, PVC, Premature Ventricular Contraction, Outflow Tract PVC, NonOutflow Tract PVC
- Medical subject headings
- Ventricular Premature Complexes, Ventricular Dysfunction, Left, Ventricular Dysfunction, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| High PVC Burden Cohort | Persistent, high PVC Burden (>5%) in 24h Holter Monitoring Receives: Drug: Flecainide (monotherapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PVC Burden Reduction
Change in 24-hour Holter-measured PVC burden from baseline to 3 years. Unit of Measure: Percent (%)
Measured: 3 years
Secondary outcomes (4)
Change in Left Ventricular Ejection Fraction (LVEF)
- Measured by echocardiography.
- Unit: Percent (%)
Measured: 3 years
Safety and tolerability of flecainide
- Incidence of adverse effects (e.g., proarrhythmia, dizziness).
- Unit: Number of participants with event
Measured: 3 years
Symptom improvement (Questionnaire Score)
- Structured patient-reported symptom score (palpitations, fatigue, etc.). • Unit: Score on scale (e.g., 0-10)
Measured: 3 years
Treatment Adherence and Dose Adjustments
- Rate of dose changes or discontinuation due to side effects.
- Unit: Number of participants
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start26 Apr 2024
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Ventricular BeatsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Athens
- Sponsor type
- University, hospital or other
- Collaborators
- Institute for Study, Research, Education and Therapy of Vascular, Heart, Brain and Kidney Nosologies, University of Patras, University General Hospital of Heraklion, Aristotle University Of Thessaloniki, Uni-Pharma
- Responsible party
- Principal investigator, Tsiachris Dimitrios, University of Athens
- Investigators
- Dimitrios Tsiachris, MD, PhD, Study chair, University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06949748
- Sponsor's protocol ID
- 8014/25-04-2024
- Acronym
- UNIFLECA
- Status last verified
- Jun 2025
- First submitted
- 22 Apr 2025
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UNIFLECA Study: Prospective Cohort Study on Flecainide's Impact on Persistent High Premature Ventricular Contraction Burden and PVC-Induced Cardiomyopathy
- ClinicalTrials.gov ID
- NCT06949748
- Acronym / sponsor ID
- UNIFLECA / 8014/25-04-2024
- Conditions
- Premature Ventricular Beats, Premature Ventricular Complexes, Premature Ventricular Contraction (PVC), Arrhythmia Ventricular, Ventricular Dysfunction, Left, Ventricular Dysfunction
- Keywords
- Flecainide, Sanocard, UNIFLECA, PVC induced CMP, PVC, Premature Ventricular Contraction, Outflow Tract PVC, NonOutflow Tract PVC
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Collaborators
- Institute for Study, Research, Education and Therapy of Vascular, Heart, Brain and Kidney Nosologies, University of Patras, University General Hospital of Heraklion, Aristotle University Of Thessaloniki, Uni-Pharma
- Study start
- 26 Apr 2024 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 29 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The UNIFLECA study is a prospective, single-arm, non-randomized observational cohort designed to evaluate the long-term efficacy and safety of flecainide (in the form of Sanocard) in adult patients with frequent idiopathic premature ventricular contractions (PVCs) and suspected PVC-induced cardiomyopathy (PVCi-CMP). Despite being considered benign in structurally normal hearts, a persistently high PVC burden-particularly above 10%-is increasingly recognized as a cause of reversible left ventricular dysfunction and a potential trigger for cardiomyopathy. This condition is frequently underdiagnosed and may lead to unnecessary treatments or delayed intervention.
The study targets a unique population: symptomatic patients with idiopathic PVCs who have structurally normal hearts and have either declined catheter ablation or are ineligible for invasive procedures. Each patient undergoes comprehensive baseline cardiac evaluation, including transthoracic echocardiography, cardiac magnetic resonance imaging (CMR) to exclude late gadolinium enhancement or myocardial scar, and coronary angiography or non-invasive equivalent to rule out ischemic heart disease. Two 24-hour Holter ECG recordings, taken at least 30 days apart, are used to confirm persistent high PVC burden (>5%).
Flecainide, a Class IC antiarrhythmic agent with sodium channel-blocking properties, is administered as monotherapy. The initial dose is 100 mg/day and may be titrated up to 200 mg/day based on clinical response, patient tolerability, and QRS interval monitoring. Beta-blockers are discontinued unless used for unrelated comorbidities such as hypertension. Patients are monitored with serial 12-lead ECGs, Holter recordings, and echocardiograms at baseline and every three months over a total follow-up period of three years.
The primary endpoint is the percentage reduction in PVC burden as measured by 24-hour Holter ECG. Secondary endpoints include (1) improvement in left ventricular ejection fraction (LVEF), (2) symptom relief as assessed by structured patient questionnaires focusing on palpitations, bradysphygmia, fatigue, dizziness, and exercise intolerance, (3) incidence of adverse events including proarrhythmia, conduction disturbances, and neurological side effects, and (4) adherence to long-term flecainide therapy, including need for dose modifications or drug discontinuation.
This investigator-initiated study is being conducted across tertiary arrhythmia centers in Greece. It aims to fill a significant evidence gap in the long-term pharmacologic management of idiopathic PVCs and PVCi-CMP. Preliminary results indicate significant PVC burden reduction and symptomatic improvement, supporting the potential utility of flecainide as an effective non-invasive therapeutic option in appropriately selected patients. Data from this study will contribute to optimizing treatment strategies for idiopathic ventricular arrhythmias in the absence of structural heart disease, supporting the use of personalized medicine and risk stratification.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High PVC Burden Cohort | – | Drug: Flecainide (monotherapy)Persistent, high PVC Burden (>5%) in 24h Holter Monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flecainide (monotherapy)• 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. | Drug | High PVC Burden Cohort |
Primary outcome
PVC Burden Reduction
Time frame: 3 years
Change in 24-hour Holter-measured PVC burden from baseline to 3 years. Unit of Measure: Percent (%)
4 secondary outcomes
Change in Left Ventricular Ejection Fraction (LVEF)
Time frame: 3 years
Safety and tolerability of flecainide
Time frame: 3 years
Symptom improvement (Questionnaire Score)
Time frame: 3 years
Treatment Adherence and Dose Adjustments
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dimitrios Tsiachris, MD, PhD study chair
University of Athens
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Ventricular Beats and Premature Ventricular Complexes, run by University of Athens at 6 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dimitrios Tsiachris, MD, PhD (+306944849926, dtsiachris@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PVC Burden Reduction (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.