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

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Mar 13, 2023

Keywords

ClinConnect Summary

This clinical trial is looking to find out if giving treatment to patients with frequent premature ventricular contractions (PVCs) can help prevent future heart problems, specifically left ventricular dysfunction, over two years. Participants in the study will either receive this treatment, which may include medications and a procedure called ablation, or they will just be monitored without any therapy. The goal is to see if those receiving treatment have better heart function compared to those who don’t.

To join the study, participants must be between 18 and 85 years old, have a PVC burden of more than 10%, and have normal heart function. It's important that they do not show symptoms related to their PVCs and that they can provide consent to participate. Throughout the trial, participants can expect regular check-ins and heart assessments, including imaging tests to monitor any changes in heart function. This study is not yet recruiting, so interested individuals will need to wait for it to begin.

Gender

ALL

Eligibility 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