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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Experimental group

    Drug

    medical treatment including drug administration ± catheter ablation (Ablation can be performed if the PVC burden remain \>10% after 2 lines of AAD treatment).

  • Control group

    Drug

    patients of this group have no therapeutic or no treatment modification such as drug therapy

Treatment groups

298 Participants
are divided into 2 treatment groups
Group A: Experimental groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

occurence of Left ventricular dysfunction (PVC-iCMP)

The primary endpoint will be the development of left ventricular 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).

Time frame
24 months

Secondary outcomes

1

Rate of Death

Death from any cause

Time frame
24 months
2

Rate of Cardiovascular Death

measure of safety endpoint: Death cause of death

Time frame
24 months
3

Rate of Hospitalization for an adverse event

occurence 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

Time frame
24 months
4

Percentage of patients with a PVC burden <10%

measure of efficacy endpoints: PVC burden will be measured the second year following randomization

Time frame
during 24 months follow up

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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