Ignite Creation Date:
2025-12-24 @ 4:47 PM
Ignite Modification Date:
2025-12-25 @ 2:33 PM
Study NCT ID:
NCT04008550
Status:
TERMINATED
Last Update Posted:
2020-08-05
First Post:
2019-06-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prognostic Impact of the Evolution of PAH 3 Months After TAVI (HTP-TAVI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D000081029', 'term': 'Pulmonary Arterial Hypertension'}], 'ancestors': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'whyStopped': '* Delay in enrolment (24% at 1 year)\n* Lower than estimated prevalence of PAH (15% instead of 50%)\n* Refusal of patients with PAH to participate', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-03-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-03-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-03', 'studyFirstSubmitDate': '2019-06-26', 'studyFirstSubmitQcDate': '2019-07-02', 'lastUpdatePostDateStruct': {'date': '2020-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hospitalization for heart failure or death any cause (composite endpoint)', 'timeFrame': 'Up to 24 months', 'description': 'Time before the first event (hospitalization or death any cause)'}], 'secondaryOutcomes': [{'measure': 'Post-operative evolution of the PAH, according to the type of pre-operative PAH', 'timeFrame': 'Year 2', 'description': 'PAPm (mean pulmonary arterial pressure) measurement'}, {'measure': 'Prevalence of pre-TAVI PAH', 'timeFrame': 'Year 0', 'description': 'In percent and according to the type of PAH (pre-TAVI)'}, {'measure': 'Hospital-free survival for heart failure among the 3 types of PAH (pre-TAVI)', 'timeFrame': 'Year 2', 'description': 'Occurrence of clinical events'}, {'measure': 'Prognosis (survival without hospitalization for heart failure) of subjects whose PAH corrected post-TAVI to those who had no pre-TAVI PAH', 'timeFrame': 'Month 3', 'description': 'Occurrence of clinical events'}, {'measure': 'Concordance between the PAH measurement techniques: echocardiography and right heart catheterization', 'timeFrame': 'Month 3', 'description': 'PAPm (mean pulmonary arterial pressure) measurement (Echocardiography or right heart catheterization)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['TAVI (Transcatheter Aortic Valve Implantation)', 'Aortic Stenosis', 'Pulmonary Arterial Hypertension', 'Right Heart Catheterization'], 'conditions': ['Aortic Valve Stenosis', 'Pulmonary Hypertension']}, 'descriptionModule': {'briefSummary': 'Aortic stenosis (AS) is the most frequent valvulopathy in Western countries. The prevalence of AS is constantly increasing due to the aging of the population. Several studies have shown that pulmonary arterial hypertension (PAH) was common in AS patients referred for TAVI and that it was an independent predictor of mortality after TAVI.\n\nCurrently, there is no data in the literature regarding the evolution and prognosis value of PAH measured using right heart catheterization (reference method). PAH could either regress after TAVI or continue to progress despite the treatment of valvulopathy, resulting in a refractory right heart failure that can lead to death.\n\nThe hypothesis of this study is that patients with PAH before TAVI procedure and at the 3-month follow-up visit (PAH persistence) have an increased risk of cardiovascular mortality compared to patients with no PAH at 3 months or having a significant reduction of their PAH (PAH regression).\n\nThe aim of the study is to evaluate the prognostic impact of the evolution of PAH after TAVI in 424 patients using right heart catheterization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aortic stenosis\n* Indication of TAVI\n\nExclusion Criteria:\n\n* Contra-indication of right heart catheterization\n* Pregnancy\n* Persons deprived of their liberty'}, 'identificationModule': {'nctId': 'NCT04008550', 'acronym': 'HTP-TAVI', 'briefTitle': 'Prognostic Impact of the Evolution of PAH 3 Months After TAVI (HTP-TAVI)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Rouen'}, 'officialTitle': 'Prognostic Impact of the Evolution of Pulmonary Arterial Hypertension 3 Months After Transcatheter Aortic Valve Implantation', 'orgStudyIdInfo': {'id': '2018/093/HP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'No Pulmonary Arterial Hypertension before TAVI', 'description': 'No intervention has been done in this group of patients.'}, {'type': 'OTHER', 'label': 'Pulmonary Arterial Hypertension before TAVI', 'description': 'In this group, a right heart catheterization is done 3 months after TAVI in order to evaluate PAH (persistence or regression).', 'interventionNames': ['Procedure: Right Heart Catheterization']}], 'interventions': [{'name': 'Right Heart Catheterization', 'type': 'PROCEDURE', 'description': 'A right heart catheterization will be done in patients with PAH before TAVI (3 months after TAVI)', 'armGroupLabels': ['Pulmonary Arterial Hypertension before TAVI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76031', 'city': 'Rouen', 'country': 'France', 'facility': 'Rouen University Hospital', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}], 'overallOfficials': [{'name': 'Eric Durand, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Rouen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Rouen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}