Premature ventricular contractions (PVCs) MedDRA version: 20.0 Level: LLT Classification code 10036614 Term: Premature ventricular contractions System Organ Class: 100000004849
Conditions
Interventions
Product Name: Bisoprolol, Nebivolol
Pharmaceutical Form:
Product Name: Flécaïnide
Pharmaceutical Form:
INN or Proposed INN: FLECAINIDE
CAS Number: 54143-55-4
Product Name: Verapamil, Diltiazem
Pha
Sponsors
Assistance Publique - Hôpitaux de Paris
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) 18 = Age = 85 2) PVC burden = to 10% regardless of current or preexisting antiarrhythmic drug intake (for instance, a patient under betablocker therapy because of his PVCs or hypertension can be included) 3) Asymptomatic status 4) Normal (>or= 55%) LVEF. Patients with underlying cardiomyopathy can be included as long as LV function remains preserved. 5) Signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 288 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1) Pregnant woman or Female of childbearing potential without effective method of birth control or nursing woman. 2) Patients that can’t undergo MRI study 3) De novo requirement for antiarrhythmic drug prescription for another indication (e.g. atrial fibrillation…) 4) The physician already decided that the patient requires drug initiation or escalation; 5) Ischemic cardiomyopathy requiring revascularization (PCI or surgery) 6) History of LV dysfunction 7) Participation in another research involving the human person 8) Patient under legal protection 9) Non affiliation to a social security scheme
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the study is to demonstrate that prophylactic treatment of patients with asymptomatic frequent (>10%) PVCs is superior to simple follow-up strategy with no therapy to prevent subsequent LV dysfunction at 24 months. The prophylactic treatment is based on drugs ± ablation (ablation can be performed if the PVC burden remain >10% after 2 lines of AAD treatment since the initiation of the study).;Secondary Objective: - To evaluate the efficacy, safety, feasibility of prophylactic PVC suppression (drug +/- catheter ablation) - To prospectively assess the impact of frequent PVCs on clinical, biological and imaging endpoints and understand the chronological development of the PVC-iCMP to individualize early markers of the disease. - To identify in healthy PVCs patients, predictors of subsequent development of PVC-iCMP to improve risk stratification in this population. ;Primary end point(s): Development of LV dysfunction (PVC-iCMP) defined as a 15% relative LVEF decrease (and/or a final LVEF <50%) within 2 years following randomization, on cardiac magnetic resonance imaging (cMRI) (or transthoracic echocardiography (TTE) when not possible).;Timepoint(s) of evaluation of this end point: 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Other efficacy endpoints: • Mean PVC burden during the whole follow-up (M3, M6, M12, M18 and at M24) • Percentage of patients with a PVC burden 15% from baseline to M24 • Nt-ProBNP relative variation from baseline to M24 • Exercise capacity on treadmill (Watts, Mets, MVO2) and NYHA at baseline and M24 • Quality of life will be assessed with SF-36 (Short Form 36) scale administered for both arms at inclusion, at M12 and at M24. - Safety endpoints: • Death from any cause • Cardiovascular cause of death • Hospitalization for an adverse event • The nature, frequency, severity and outcome of adverse events (AE) and serious adverse events (SAE) within follow-up (that may be linked or not to anti-arrhythmic drugs (AAD) or ablation procedure) ;Timepoint(s) of evaluation of this end point: 2years | — |
Countries
France
Contacts
Public ContactProject Manager
Assitance Publique-Hôpitaux de Paris
Outcome results
None listed