Overview

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

Status:
Not yet recruiting

Trial end date:
2027-05-01

Target enrollment:
0

Participant gender:
All

Summary

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).

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Assistance Publique - Hôpitaux de Paris

Criteria

Inclusion Criteria:

Inclusion criteria (all must be present):

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

Exclusion criteria (any of them):

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