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

Study acronym: SUPPRESS
StatusNot Yet Recruiting
PhasePhase 4
Started2023-10-01
View on ClinicalTrials.gov ↗

Amendment history

2023-09-05
Study Status v2
Primary completion date2027-05-01→2027-06-01
Completion date2027-05-01→2027-06-01
Start date2023-05-01→2023-10-01
2023-03-27
Study Identification, Study Status, Study Description, Conditions v1
Study description+30 characters
[...] in rare cases, sudden cardiac death. For about two decades, weit knowhas been accepted that frequent PVCs may also induce left ventricular (LV) dy [...] ently, management of such patients is widely heterogeneous. WeThe hypothesizehypothesis of this study is that prophylactic suppression of very frequent PVCs (>10%) [...]
Study title-1 characters
"Prophylactic Frequent Premature Ventricular complexeS sUPPre [...]
2023-03-13
Original filing
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).
Trial Details
NCT Number NCT05784051
Lead Sponsor Assistance Publique - Hôpitaux de Paris
Conditions Premature Ventricular Contractions, Ventricular Dysfunction, Left
Enrollment 298 participants
Start Date 2023-10-01
Primary Completion 2027-06-01 (estimated)
Study Completion 2027-06-01 (estimated)
Updated on ClinicalTrials.gov 2023-09-06