Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2025-12-25 @ 11:16 PM
Study NCT ID:
NCT04286893
Status:
COMPLETED
Last Update Posted:
2020-11-10
First Post:
2020-02-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Improved HRV, Inflammation Markers and Endothelial Function After TAVI
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 withdrawal for endothelial inflammation markers detection'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-08', 'studyFirstSubmitDate': '2020-02-21', 'studyFirstSubmitQcDate': '2020-02-25', 'lastUpdatePostDateStruct': {'date': '2020-11-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of heart rate variability', 'timeFrame': '3 to 6 months after TAVI', 'description': 'Change of heart rate variability (HRV) estimated with digital high resolution ECG recording'}, {'measure': 'Change of laboratory value of endothelial inflammation markers', 'timeFrame': '3 to 6 months after TAVI', 'description': 'Laboratory determined numerical changes in endothelial inflammation markers'}, {'measure': 'Change of flow-mediated filatation (FMD) of the brachial artery', 'timeFrame': '3 to 6 months after TAVI', 'description': '% flow-mediated dilatation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Severe Aortic Stenosis', 'TAVI']}, 'referencesModule': {'references': [{'pmid': '25287265', 'type': 'RESULT', 'citation': 'Horn P, Stern D, Veulemans V, Heiss C, Zeus T, Merx MW, Kelm M, Westenfeld R. Improved endothelial function and decreased levels of endothelium-derived microparticles after transcatheter aortic valve implantation. EuroIntervention. 2015 Apr;10(12):1456-63. doi: 10.4244/EIJY14M10_02.'}, {'pmid': '39076751', 'type': 'DERIVED', 'citation': 'Vitez L, Starc V, Jug B, Bunc M. Improved Endothelial and Autonomic Function after Transcatheter Aortic Valve Implantation. Rev Cardiovasc Med. 2023 May 8;24(5):140. doi: 10.31083/j.rcm2405140. eCollection 2023 May.'}]}, 'descriptionModule': {'briefSummary': 'Severe aortic valve stenosis is known to affect heart haemodynamics, endothelial function and body inflammation markers. Our aim is to investigate the weather transcatheter aortic valve implantation in patients with severe aortic stenosis affects heart rate variability, inflammation markers and endothelial function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients eligible for transfemoral transcatheter aortic valve implantation', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* TAVI\n\nExclusion Criteria:\n\n* stage V chronic kidney disease\n* active malignancies'}, 'identificationModule': {'nctId': 'NCT04286893', 'acronym': 'bTAVI', 'briefTitle': 'Improved HRV, Inflammation Markers and Endothelial Function After TAVI', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Centre Ljubljana'}, 'officialTitle': 'Improved Heart Rate Variability, Inflammation Markers and Endothelial Function After Transcatheter Aortic Valve Implantation', 'orgStudyIdInfo': {'id': 'UKCLbTAVI'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'TAVI group', 'description': 'Consecutive patients undergoing TAVI', 'interventionNames': ['Diagnostic Test: Flow mediated vasodilatation', 'Diagnostic Test: High resolution ECG', 'Diagnostic Test: Blood withdrawal']}], 'interventions': [{'name': 'Flow mediated vasodilatation', 'type': 'DIAGNOSTIC_TEST', 'description': 'Measurement of brachial artery diameter change before and after limb ischaemia.', 'armGroupLabels': ['TAVI group']}, {'name': 'High resolution ECG', 'type': 'DIAGNOSTIC_TEST', 'description': 'Measurement HRV using high resolution ECG', 'armGroupLabels': ['TAVI group']}, {'name': 'Blood withdrawal', 'type': 'DIAGNOSTIC_TEST', 'description': 'Measurement of endothelial inflammation markers', 'armGroupLabels': ['TAVI group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Ljubljana', 'country': 'Slovenia', 'facility': 'UMC Ljubljana', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}], 'overallOfficials': [{'name': 'Borut Jug, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Medical Centre Ljubljana'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Centre Ljubljana', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Luka Vitez, MD, cardiology resident', 'investigatorFullName': 'Luka Vitez', 'investigatorAffiliation': 'University Medical Centre Ljubljana'}}}}