Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:19 AM
Study NCT ID:
NCT05272020
Status:
UNKNOWN
Last Update Posted:
2022-03-09
First Post:
2022-02-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Outcome, Recuperation and Hemodynamics in Aortic Stenosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005080', 'term': 'Exercise Test'}], 'ancestors': [{'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D016552', 'term': 'Ergometry'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2024-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-28', 'studyFirstSubmitDate': '2022-02-28', 'studyFirstSubmitQcDate': '2022-02-28', 'lastUpdatePostDateStruct': {'date': '2022-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Outcome defined by the occurrence of a major cardiac event', 'timeFrame': '18 months', 'description': 'either\n\n1. Death of cardiovascular origin, or\n2. Hospitalization for heart failure, or\n3. Deterioration of hemodynamic function during an 18 month follow-up period after AVR.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aortic Valve Stenosis']}, 'descriptionModule': {'briefSummary': 'Indication for aortic valve replacement (AVR) in aortic stenosis (AS) is currently based on the classical triad of clinical AS symptoms, estimation of AS severity, and cardiac repercussion at rest. However, presence of symptoms in elderly is often subjective and underreported, and cardiac function analysis at rest underestimates the true impact of the chronic afterload increase. This complicates the diagnosis and hampers timely aortic valve replacement therapy with an impact on prognosis and cardiac function recovery. Exercise imaging in AS may reveal underlying cardiac repercussion and symptoms at an earlier stage and therefore impact prognosis and cardiac function recovery after AVR. Therefore the principal objective of this study is to reveal the factors that determine clinical outcome and hemodynamic function recovery after AVR in AS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Every patient above 18 years of age with an echocardiographic established moderate to severe AS\n* A guideline indication for aortic valve replacement therapy\n\nExclusion Criteria:\n\n* Unable to perform exercise testing\n* Previous aortic valve intervention\n* More than moderate other valvular disease\n* Patients refusing participation or unwilling to sign the informed consent'}, 'identificationModule': {'nctId': 'NCT05272020', 'acronym': 'PROCARE-AS', 'briefTitle': 'Outcome, Recuperation and Hemodynamics in Aortic Stenosis', 'organization': {'class': 'OTHER', 'fullName': 'Jessa Hospital'}, 'officialTitle': 'PRognosis of Outcome and Recuperation of Cardiac Hemodynamic Function After Aortic Valve REplacement in Aortic Valve Stenosis', 'orgStudyIdInfo': {'id': 'f/2020/173'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'TAVI', 'description': 'Cardiopulmonary exercise testing, 6 minute walking test, QOL assessment', 'interventionNames': ['Diagnostic Test: CPET, 6MWT, QOL assessment']}, {'type': 'OTHER', 'label': 'AVR', 'description': 'Cardiopulmonary exercise testing, 6 minute walking test, QOL assessment, Myocardial + aortic valve biopsy', 'interventionNames': ['Diagnostic Test: CPET, 6MWT, QOL assessment']}], 'interventions': [{'name': 'CPET, 6MWT, QOL assessment', 'type': 'DIAGNOSTIC_TEST', 'description': 'Preoperative and postoperative (6 months + 18 months) assessment', 'armGroupLabels': ['AVR', 'TAVI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3500', 'city': 'Hasselt', 'state': 'Limburg', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Sarah Hoedemakers', 'role': 'CONTACT', 'email': 'sarahhoed@gmail.com', 'phone': '0498260617'}], 'facility': 'Jessa Ziekenhuis', 'geoPoint': {'lat': 50.93106, 'lon': 5.33781}}], 'centralContacts': [{'name': 'Sarah Hoedemakers, MD', 'role': 'CONTACT', 'email': 'sarahhoed@gmail.com', 'phone': '+32498260617'}], 'overallOfficials': [{'name': 'Lieven Herbots, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jessa Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jessa Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Sarah Hoedemakers', 'investigatorFullName': 'Sarah Hoedemakers', 'investigatorAffiliation': 'Jessa Hospital'}}}}