Prophylactic Frequent Premature Ventricular complexeS sUPPression on Left ventriculaR Function impairmEnt in aSymptomatic patientS

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-85
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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).

The primary endpoint will be the development of LV dysfunction (PVC-iCMP) defined as a 15% relative LVEF decrease (and/or a LVEF \<50%) within 2 years following randomization, on cardiac magnetic resonance imaging (cMRI) (or transthoracic echocardiography (TTE) when not possible).

Eligibility criteria

Qualifiers

18 ≤ Age ≤ 85

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)

Asymptomatic status

Normal (>or= 55%) LVEF. Patients with underlying cardiomyopathy can be included as long as LV function remains preserved.

Disqualifiers

Pregnant woman or Female of childbearing potential without effective method of birth control or nursing woman.

Patients that can't undergo MRI study

De novo requirement for antiarrhythmic drug prescription for another indication (e.g. atrial fibrillation…)

The physician already decided that the patient requires drug initiation or escalation;

Trial design

Treatments tested in this trial

  • Experimental group
  • Control group

Treatment groups

298 Participants
are divided into 2 treatment groups

Locations

This trial has no locations