Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2026-03-06 @ 3:32 AM
Study NCT ID:
NCT02174133
Status:
COMPLETED
Last Update Posted:
2015-03-10
First Post:
2014-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of LVAD Implantation on Micro- and Macrovascular Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-09', 'studyFirstSubmitDate': '2014-06-24', 'studyFirstSubmitQcDate': '2014-06-24', 'lastUpdatePostDateStruct': {'date': '2015-03-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Macrovascular function measured by flow-mediated vasodilation (FMD)', 'timeFrame': '3 months after implantation'}], 'secondaryOutcomes': [{'measure': 'Microvascular function assessed by non-invasive laser Doppler imaging', 'timeFrame': '3 months after implantation'}, {'measure': 'microparticles determined by Flow Cytometry', 'timeFrame': '3 months after implantation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['left ventricular assist device', 'endothelial function', 'microvascular perfusion', 'microparticles'], 'conditions': ['End Stage Heart Failure']}, 'descriptionModule': {'briefSummary': "End stage heart failure is characterized by a critical inability of the heart to meet the organism's blood demand even under resting conditions. Heart transplantation (HTx) is the established therapeutic approach in the treatment of end stage heart failure and still the gold standard treatment. Left ventricular assist devices (LVADs) are considered as a vital therapeutic option to temporarily or permanently assist the failing circulation. The hemodynamic vascular consequences of implanting LVADs have not been studied in detail. The aim of the study is to investigate the effect of LVAD implantation compared to heart transplant (HTx) on micro- and macrovascular function in patients with end stage heart failure."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with end stage heart failure', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients after HTX\n* patients after LVAD implantation\n* patients with stable coronary heart disease and normal systolic left ventricular function\n* healthy volunteers\n* written informed consent\n\nExclusion Criteria:\n\n* acute inflammation\n* cardiac arrhythmia\n* renal failure\n* malignant disease'}, 'identificationModule': {'nctId': 'NCT02174133', 'acronym': 'LVAD', 'briefTitle': 'Impact of LVAD Implantation on Micro- and Macrovascular Function', 'organization': {'class': 'OTHER', 'fullName': 'Heinrich-Heine University, Duesseldorf'}, 'officialTitle': 'Impact of LVAD Implantation on Micro- and Macrovascular Function', 'orgStudyIdInfo': {'id': 'LVAD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients after HTX'}, {'label': 'patients after LVAD implantation'}, {'label': 'patients with coronary heart disease'}, {'label': 'healthy volunteers'}]}, 'contactsLocationsModule': {'locations': [{'zip': '40225', 'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Division of Cardiology, Pulmonology and Vascular Medicine Duesseldorf,', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}], 'overallOfficials': [{'name': 'Christian Heiss, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Cardiology, Pulmonology and Vascular Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Klinik für Kardiologie, Pneumologie und Angiologie', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Division of Cardiology, Pulmonary Diseases, Vascular Medicine', 'investigatorFullName': 'Klinik für Kardiologie, Pneumologie und Angiologie', 'investigatorAffiliation': 'Heinrich-Heine University, Duesseldorf'}}}}