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

Primary Purpose

Premature Ventricular Contractions, Ventricular Dysfunction, Left

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Experimental group
Control group
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Premature Ventricular Contractions

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Inclusion criteria (all must be present): 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. Signed informed consent Exclusion criteria (any of them): 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; Ischemic cardiomyopathy requiring revascularization (PCI or surgery) History of LV dysfunction Participation in another research involving the human person Patient under legal protection Non affiliation to a social security scheme

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Experimental group

    Control group

    Arm Description

    Patients treated for PVCs with drug therapy and/or catheter ablation/ medical treatment including drug administration ± catheter ablation (Ablation can be performed if the PVC burden remain >10% after 2 lines of AAD treatment).

    Patients with therapeutic abstention or no treatment modification such as drug therapy/ Therapeutic abstention or no modification of therapy

    Outcomes

    Primary Outcome Measures

    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).

    Secondary Outcome Measures

    Rate of Death
    Death from any cause
    Rate of Cardiovascular Death
    measure of safety endpoint: Death cause of death
    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
    Percentage of patients with a PVC burden <10%
    measure of efficacy endpoints: PVC burden will be measured the second year following randomization
    LVEF variation
    LVEF variation(from baseline to M24)
    Nt-ProBNP relative variation
    Nt-ProBNP relative variation from baseline to M24

    Full Information

    First Posted
    March 13, 2023
    Last Updated
    September 5, 2023
    Sponsor
    Assistance Publique - Hôpitaux de Paris
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05784051
    Brief Title
    Prophylactic Frequent Premature Ventricular complexeS sUPPression on Left ventriculaR Function impairmEnt in aSymptomatic patientS
    Acronym
    SUPPRESS
    Official Title
    Prophylactic Frequent Premature Ventricular complexeS sUPPression on Left ventriculaR Function impairmEnt in aSymptomatic patientS
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    June 1, 2027 (Anticipated)
    Study Completion Date
    June 1, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Assistance Publique - Hôpitaux de Paris

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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).
    Detailed Description
    Premature ventricular contractions (PVCs) are frequently encountered in clinical practice, in the setting of underlying heart disease as well as in "normal" hearts. Frequent PVCs have been shown to impact long term prognosis in patients with structurally normal hearts,[1] as well as in documented cardiomyopathy. In both settings, PVCs may cause symptoms and, in rare cases, sudden cardiac death. For about two decades, it has been accepted that frequent PVCs may also induce left ventricular (LV) dysfunction called PVC-induced cardiomyopathy (PVC-iCMP). Indeed, PVC suppression by using drugs or catheter ablation has been associated with full recovery of left ventricular dysfunction.[2-4] De facto, PVC-iCMP diagnosis as well as identification of predictors has always been established retrospectively. Therefore, risk stratification or simply knowing the exact incidence of the disease in exposed patients remain difficult. European and US guidelines recommend to treat symptomatic PVC patients regardless of the burden or their risk profile, as well as "frequent PVCs" associated with LV dysfunction (Experts tend to consider worthwhile treating for burden >10%, which was the lowest burden associated with PVC-iCMP). However, there is no clear recommendation for asymptomatic patients exposed to very frequent PVCs, at risk of developing cardiomyopathy. As no previous studies included such population, expert suggested that these patients should be at least closely followed. Consequently, management of such patients is widely heterogeneous. The hypothesis of this study is that prophylactic suppression of very frequent PVCs (>10%) will prevent or significantly reduce the incidence of PVC-iCMP.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Premature Ventricular Contractions, Ventricular Dysfunction, Left

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    The SUPPRESS study will be a national multicenter randomized open label trial using the PROBE study design (Prospective Randomized Open Blinded End-point). Patients fulfilling the inclusion criteria (asymptomatic patients with frequent (> 10%/day) PVCs and normal LVEF) and without any exclusion criteria that agree to enter the protocol will be randomized to: Experimental group: 149 patients treated for PVCs with drug therapy and/or catheter ablation/ 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: 149 patients with therapeutic abstention or no treatment modification such as drug therapy/ Therapeutic abstention or no modification of therapy
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    298 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental group
    Arm Type
    Experimental
    Arm Description
    Patients treated for PVCs with drug therapy and/or catheter ablation/ medical treatment including drug administration ± catheter ablation (Ablation can be performed if the PVC burden remain >10% after 2 lines of AAD treatment).
    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    Patients with therapeutic abstention or no treatment modification such as drug therapy/ Therapeutic abstention or no modification of therapy
    Intervention Type
    Drug
    Intervention Name(s)
    Experimental group
    Other Intervention Name(s)
    medical treatment
    Intervention Description
    medical treatment including drug administration ± catheter ablation (Ablation can be performed if the PVC burden remain >10% after 2 lines of AAD treatment).
    Intervention Type
    Drug
    Intervention Name(s)
    Control group
    Other Intervention Name(s)
    Therapeutic abstention or no modification of therapy
    Intervention Description
    patients of this group have no therapeutic or no treatment modification such as drug therapy
    Primary Outcome Measure Information:
    Title
    occurence of Left ventricular dysfunction (PVC-iCMP)
    Description
    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 Outcome Measure Information:
    Title
    Rate of Death
    Description
    Death from any cause
    Time Frame
    24 months
    Title
    Rate of Cardiovascular Death
    Description
    measure of safety endpoint: Death cause of death
    Time Frame
    24 months
    Title
    Rate of Hospitalization for an adverse event
    Description
    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
    Title
    Percentage of patients with a PVC burden <10%
    Description
    measure of efficacy endpoints: PVC burden will be measured the second year following randomization
    Time Frame
    during 24 months follow up
    Title
    LVEF variation
    Description
    LVEF variation(from baseline to M24)
    Time Frame
    24 months
    Title
    Nt-ProBNP relative variation
    Description
    Nt-ProBNP relative variation from baseline to M24
    Time Frame
    24 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Inclusion criteria (all must be present): 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. Signed informed consent Exclusion criteria (any of them): 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; Ischemic cardiomyopathy requiring revascularization (PCI or surgery) History of LV dysfunction Participation in another research involving the human person Patient under legal protection Non affiliation to a social security scheme

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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