Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-29 @ 8:26 PM
Study NCT ID:
NCT05784051
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-09-06
First Post:
2023-03-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prophylactic Frequent Premature Ventricular complexeS sUPPression on Left ventriculaR Function impairmEnt in aSymptomatic patientS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018879', 'term': 'Ventricular Premature Complexes'}, {'id': 'D018487', 'term': 'Ventricular Dysfunction, Left'}], 'ancestors': [{'id': 'D005117', 'term': 'Cardiac Complexes, Premature'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D018754', 'term': 'Ventricular Dysfunction'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The SUPPRESS study will be a national multicenter randomized open label trial using the PROBE study design (Prospective Randomized Open Blinded End-point).\n\nPatients 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:\n\n1. 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).\n2. Control group: 149 patients with therapeutic abstention or no treatment modification such as drug therapy/ Therapeutic abstention or no modification of therapy'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 298}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2027-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-05', 'studyFirstSubmitDate': '2023-03-13', 'studyFirstSubmitQcDate': '2023-03-13', 'lastUpdatePostDateStruct': {'date': '2023-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'occurence of Left ventricular dysfunction (PVC-iCMP)', 'timeFrame': '24 months', '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).'}], 'secondaryOutcomes': [{'measure': 'Rate of Death', 'timeFrame': '24 months', 'description': 'Death from any cause'}, {'measure': 'Rate of Cardiovascular Death', 'timeFrame': '24 months', 'description': 'measure of safety endpoint: Death cause of death'}, {'measure': 'Rate of Hospitalization for an adverse event', 'timeFrame': '24 months', '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'}, {'measure': 'Percentage of patients with a PVC burden <10%', 'timeFrame': 'during 24 months follow up', 'description': 'measure of efficacy endpoints:\n\nPVC burden will be measured the second year following randomization'}, {'measure': 'LVEF variation', 'timeFrame': '24 months', 'description': 'LVEF variation(from baseline to M24)'}, {'measure': 'Nt-ProBNP relative variation', 'timeFrame': '24 months', 'description': 'Nt-ProBNP relative variation from baseline to M24'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Premature Ventricular Contractions', 'Ventricular Dysfunction, Left']}, 'descriptionModule': {'briefSummary': '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).\n\nThe 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).', 'detailedDescription': '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.\n\nEuropean 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).\n\nHowever, 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.\n\nThe hypothesis of this study is that prophylactic suppression of very frequent PVCs (\\>10%) will prevent or significantly reduce the incidence of PVC-iCMP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nInclusion criteria (all must be present):\n\n1. 18 ≤ Age ≤ 85\n2. 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)\n3. Asymptomatic status\n4. Normal (\\>or= 55%) LVEF. Patients with underlying cardiomyopathy can be included as long as LV function remains preserved.\n5. Signed informed consent\n\nExclusion criteria (any of them):\n\n1. Pregnant woman or Female of childbearing potential without effective method of birth control or nursing woman.\n2. Patients that can't undergo MRI study\n3. De novo requirement for antiarrhythmic drug prescription for another indication (e.g. atrial fibrillation…)\n4. The physician already decided that the patient requires drug initiation or escalation;\n5. Ischemic cardiomyopathy requiring revascularization (PCI or surgery)\n6. History of LV dysfunction\n7. Participation in another research involving the human person\n8. Patient under legal protection\n9. Non affiliation to a social security scheme"}, 'identificationModule': {'nctId': 'NCT05784051', 'acronym': 'SUPPRESS', 'briefTitle': 'Prophylactic Frequent Premature Ventricular complexeS sUPPression on Left ventriculaR Function impairmEnt in aSymptomatic patientS', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Prophylactic Frequent Premature Ventricular complexeS sUPPression on Left ventriculaR Function impairmEnt in aSymptomatic patientS', 'orgStudyIdInfo': {'id': 'APHP180618'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', '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).', 'interventionNames': ['Drug: Experimental group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Patients with therapeutic abstention or no treatment modification such as drug therapy/ Therapeutic abstention or no modification of therapy', 'interventionNames': ['Drug: Control group']}], 'interventions': [{'name': 'Experimental group', 'type': 'DRUG', 'otherNames': ['medical treatment'], 'description': 'medical treatment including drug administration ± catheter ablation (Ablation can be performed if the PVC burden remain \\>10% after 2 lines of AAD treatment).', 'armGroupLabels': ['Experimental group']}, {'name': 'Control group', 'type': 'DRUG', 'otherNames': ['Therapeutic abstention or no modification of therapy'], 'description': 'patients of this group have no therapeutic or no treatment modification such as drug therapy', 'armGroupLabels': ['Control group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}