Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-01-04 @ 3:44 AM
Study NCT ID:
NCT05629104
Status:
RECRUITING
Last Update Posted:
2022-11-29
First Post:
2020-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prediction of Long-term Outcome in Aortic Stenosis After Valve Intervention
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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-16', 'studyFirstSubmitDate': '2020-07-17', 'studyFirstSubmitQcDate': '2022-11-16', 'lastUpdatePostDateStruct': {'date': '2022-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Semiquantitative assessment of protein levels associated with myocardial performance', 'timeFrame': 'One year after intervention.', 'description': 'Level of normalized protein expression (NPX) in plasma, assessed by a multiplex proximity extension assay panel (Olink Bioscience, Uppsala, Sweden).'}, {'measure': 'Imaging parameters associated with clinical outcome after intervention', 'timeFrame': 'One year after intervention', 'description': 'Global longitudinal strain (%) of the right and left ventricle. The clinical outcome defined as a combination of mortality and hospitalization of heart failure'}, {'measure': 'Semiquantitative assessment of protein levels associated with myocardial performance associated with clinical outcome after intervention', 'timeFrame': 'Two years after intervention', 'description': 'Level of normalized protein expression (NPX) in plasma, assessed by a multiplex proximity extension assay panel (Olink Bioscience, Uppsala, Sweden). The clinical outcome defined as a combination of mortality and hospitalization for heart failure.'}], 'secondaryOutcomes': [{'measure': 'Imaging parameters associated with clinical outcome after intervention', 'timeFrame': 'Two years after intervention', 'description': 'Volumes of the right and left ventricle (mL/m2). The clinical outcome defined as a combination of mortality and hospitalization for heart failure.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aortic Stenosis']}, 'descriptionModule': {'briefSummary': 'Patients with severe aortic stenosis accepted for transcatheter intervention or open surgery are included before the intervention, and then followed up with clinical visits during the first year after intervention. Imaging with echocardiography and computed tomography (CT) are performed together with additional imaging with magnetic resonance imaging (MRI) and Positron emissions tomography (PET)-CT in a subgroup of the study population. Blood samples, physical performance and questionnaires with focus on frailty and heart failure are also collected at each visit. A follow up with information of the outcomes after 2-5 years will be performed through national registries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients accepted for aortic valve intervention due to aortic stenosis', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Accepted for aortic valve intervention\n\nExclusion Criteria:\n\n* No able to follow the study protocol'}, 'identificationModule': {'nctId': 'NCT05629104', 'briefTitle': 'Prediction of Long-term Outcome in Aortic Stenosis After Valve Intervention', 'organization': {'class': 'OTHER', 'fullName': 'Uppsala University'}, 'officialTitle': 'Biological Valve Prosthesis in Aortic Stenosis - Imaging, Biomarkers, Physical Performance and Patient Related Factors Predictive to Long-term Outcome (Bio-AS)', 'orgStudyIdInfo': {'id': 'Bio-AS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Preserved heart function', 'description': 'The group will be defined as preserved left ventricular ejection fraction (LVEF) with and without hypertrophy and with and without reduced global longitudinal strain (GLS).', 'interventionNames': ['Other: There is no intervention since it is an observational study patients are treated according to clinical praxis']}, {'label': 'Reduced heart function', 'description': 'The group will be defined as reduced LVEF', 'interventionNames': ['Other: There is no intervention since it is an observational study patients are treated according to clinical praxis']}], 'interventions': [{'name': 'There is no intervention since it is an observational study patients are treated according to clinical praxis', 'type': 'OTHER', 'description': 'No intervention', 'armGroupLabels': ['Preserved heart function', 'Reduced heart function']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75185', 'city': 'Uppsala', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Christina Christersson, MD PhD', 'role': 'CONTACT', 'email': 'christina.christersson@medsci.uu.se', 'phone': '+46186119068'}], 'facility': 'Department of cardiology Uppsala University Hospital', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'centralContacts': [{'name': 'Christina Christersson, MD PhD', 'role': 'CONTACT', 'email': 'christina.christersson@medsci.uu.se', 'phone': '+46186119068'}], 'overallOfficials': [{'name': 'Christina Christersson, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VO hjärt-lungmedicin och klinisk fysiologi Akademiska Sjukhuset'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uppsala University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}