Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-01-22 @ 8:54 AM
Study NCT ID:
NCT03308435
Status:
TERMINATED
Last Update Posted:
2023-01-11
First Post:
2017-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of TF-TAVR on Emotional Status, Quality of Life, Frailty and Inflammation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D007249', 'term': 'Inflammation'}], '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': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Plasma, serum and blood cells will be collected'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'futility', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-09', 'studyFirstSubmitDate': '2017-10-07', 'studyFirstSubmitQcDate': '2017-10-11', 'lastUpdatePostDateStruct': {'date': '2023-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Aortic valve area', 'timeFrame': '6 months', 'description': 'valve area as measured calculated by doppler echocardiography'}], 'secondaryOutcomes': [{'measure': 'HAMD-17 (Hamilton)', 'timeFrame': '6 months', 'description': 'questionaire score'}, {'measure': 'BDI-II', 'timeFrame': '6 months', 'description': 'Beck depression inventory score'}, {'measure': 'SF-36', 'timeFrame': '6 months', 'description': 'short form-36 questionaire'}, {'measure': 'PTSS-10', 'timeFrame': '6 months', 'description': 'Post traumatic syndrome scale-10'}, {'measure': 'Euro-QoL5D', 'timeFrame': '6 Months', 'description': 'Quality of life questionaire'}, {'measure': 'hand grip strenght test', 'timeFrame': '6 months', 'description': 'hand grip strenght test'}, {'measure': 'BIA', 'timeFrame': '6 Months', 'description': 'Bioelectrical impedance analysis'}, {'measure': 'kynurenine acid', 'timeFrame': '6 months', 'description': 'inflammatory marker'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aortic Valve Stenosis', 'Clinical Trial', 'Depression', 'Frail Elderly Syndrome', 'Inflammation']}, 'descriptionModule': {'briefSummary': 'Aortic valve stenosis (AS) shows high and increasing prevalence in Western civilizations and leads to high morbidity and mortality. 15 years ago Alain Cribier performed the first catheter-based transfemoral aortic valve replacement at the University of Rouon. This historical step initiated a dramatic shift in the treatment of AS with more than 50% of patients being treated interventionally instead of the surgical approach, today.\n\nComorbidities are major determinants of cardiovascular events and clinical outcome in aortic valve stenosis but little is known about psychiatric comorbidities or frailty in these patients. Data from our group suggest an inflammatory trigger for depression and potentially other psychiatric diseases and aortic valve stenosis as well as aortic valve replacement are associated with considerable changes in the inflammatory state of the patients. However, no study has prospectively examined the interaction of these inflammatory markers and mood disorders, yet. In addition, frailty is a key aspect of many of TAVR patients clinically, however, scientifically there is only emerging data with half of all PubMed-indexed publications being less than 18 months old and clinical use of various scores still under discussion.\n\nThe " Effect of interventional aortic valve replacement on emotional status, quality of life, frailty and inflammation"-study is designed to fill these gaps in evidence. It will be a prospective epidemiological cohort study to recruit 102 patients with symptomatic severe aortic valve stenosis within 18 months. All of these patients will undergo standardized cardiologic, psychiatric and frailty assessment as well as a sophisticated laboratory analysis focussing on the inflammatory state. The study aims to integrate these interdisciplinary findings to optimize patient treatment.', 'detailedDescription': 'Aortic valve stenosis (AS) shows a high prevalence in Western civilizations with an increasing incidence and is associated with high morbidity and mortality. AS is a degenerative disease and therefore the main reason for the increasing prevalence is the higher proportion of elderly patients in western societies. Untreated symptomatic AS is characterized by severe morbidity with mainly dyspnea, orthopnea and reduced exercise capacity. In addition, AS has a very high mortality (50-90% in 2 years), most often due to lung edema as a result of increased afterload of the left ventricle. So far, there is no medical treatment available improving mortality in these patients. For decades, the only known therapy has been surgical aortic valve replacement (SAVR), having shown a dramatic reduction in mortality. However, many of the patients suffering from AS are octogenarians or even older and also suffer from multiple comorbidities. Thus, many of these patients are considered inoperable using a surgical approach. Exactly 15 years ago Alain Cribier performed the first catheter-based transfemoral aortic valve replacement at the University of Rouon. This historical step initiated a dramatic shift in the treatment of AS with more than 50% of patients being treated interventionally instead of the surgical approach, today.\n\nComorbidities are major determinants of cardiovascular events and clinical outcome in aortic valve stenosis but little is known about psychiatric comorbidities or frailty in these patients. Data from our group suggest an inflammatory trigger for depression and potentially other psychiatric diseases and aortic valve stenosis as well as aortic valve replacement are associated with considerable changes in the inflammatory state of the patients. However, no study has prospectively examined the interaction of these inflammatory markers and mood disorders, yet. In addition, frailty is a key aspect of many of TAVR patients clinically, however, scientifically there is only emerging data with half of all PubMed-indexed publications being less than 12 months old and clinical use of various scores still under discussion.\n\nThe " Effect of interventional aortic valve replacement on emotional status, quality of life, frailty and inflammation"-study is designed to fill these gaps in evidence. It will be a prospective epidemiological cohort study to recruit 102 patients with symptomatic severe aortic valve stenosis within 18 months. All of these patients will undergo standardized cardiologic, psychiatric and frailty assessment as well as a sophisticated laboratory analysis focussing on the inflammatory state. The study aims to integrate these interdisciplinary findings to optimize patient treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with aortic valve stenosis scheduled for transfemoral aortic valve replacement', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptomatic aortic valve stenosis\n* Planned elective transcatheter aortic valve replacement\n* Willingness and ability to provide signed informed consent (IC) form prior to participation in any study-related procedures\n\nExclusion Criteria:\n\n* Disease reducing life expectancy to \\< 1 year\n* Severe immune-system modulating or -affecting disease'}, 'identificationModule': {'nctId': 'NCT03308435', 'briefTitle': 'Effect of TF-TAVR on Emotional Status, Quality of Life, Frailty and Inflammation', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Graz'}, 'officialTitle': 'Effect of Transfemoral Transcatheter Aortic Valve Replacement (TF-TAVR) on Emotional Status, Quality of Life, Frailty and Inflammation and Their Interactions', 'orgStudyIdInfo': {'id': '29-371 ex 16/17'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Geriatric assessment', 'type': 'DIAGNOSTIC_TEST', 'description': 'the assessment includes functional tests (hand grip strength, SPPB (Short Physical Performance Battery)) and questionaires Euro-QoL 5D, LUTS, GDS, ADL, iADL, dietary recall).'}, {'name': 'Psychiatric assessment', 'type': 'DIAGNOSTIC_TEST', 'description': 'Psychiatric assessments includes HAMD-17 as well as Beck depression inventory, hospital anxiety and depression scale, SF36, PTSS-10'}, {'name': 'Inflammatory assessment', 'type': 'DIAGNOSTIC_TEST', 'description': 'analysis will include arginase, ADMA, SDMA, homoarginine, aminoacids + metabolites, tryptophan, kynurenine, kynurenine acid, cortisol, ACTH, Metanephrine, myeloperoxidase,'}, {'name': 'Cardiological assessment', 'type': 'DIAGNOSTIC_TEST', 'description': 'ECG, echocardiography'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8010', 'city': 'Graz', 'country': 'Austria', 'facility': 'Medical University of Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}], 'overallOfficials': [{'name': 'Albrecht Schmidt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Graz'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'data will be shared with cooperating colleagues of the geriatric, psychiatric and laboratory departments'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Graz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof.', 'investigatorFullName': 'Dirk von Lewinski', 'investigatorAffiliation': 'Medical University of Graz'}}}}