Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-26 @ 2:02 AM
Study NCT ID:
NCT03371394
Status:
UNKNOWN
Last Update Posted:
2019-08-14
First Post:
2017-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fluid Status in Valvular Heart Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D004487', 'term': 'Edema'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2020-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-08-12', 'studyFirstSubmitDate': '2017-12-07', 'studyFirstSubmitQcDate': '2017-12-07', 'lastUpdatePostDateStruct': {'date': '2019-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiovascular outcome', 'timeFrame': '3 years', 'description': 'composition of hospitalization due to heart failure and cardiovascular death'}], 'secondaryOutcomes': [{'measure': 'Severity of valvular heart disease', 'timeFrame': 'baseline', 'description': 'BCM and association with valvular severity assessed using integrated approach to current guidelines for valvular heart disease'}, {'measure': 'NT-proBNP', 'timeFrame': 'baseline', 'description': 'BCM and association with NT-proBNP'}, {'measure': 'Clinical status (NYHA functional class)', 'timeFrame': 'baseline', 'description': 'BCM and association with NYHA functional class'}, {'measure': 'Renal impairment', 'timeFrame': 'baseline', 'description': 'BCM and association with renal impariment (eGFR)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Valvular Heart Disease', 'Fluid Overload', 'Cardiovascular Risk Factor']}, 'descriptionModule': {'briefSummary': 'By bioelectrical impedance spectroscopy (BIS) association of fluid status in patients with valvular heart disease and cardiovascular outcome will be assessed.', 'detailedDescription': 'Volume overload and abnormal fluid distribution are hallmarks in the syndromes of acute and chronic heart failure (HF) as well as valvular heart disease (VHD). Most patients, at some point in their disease progression, present acutely to an emergency department, where they will typically show symptoms of progressive volume overload.\n\nMost patients respond well to standard diuretic therapy, usually at the costs of impaired renal function. Based on the assumption that clinically overt fluid overload is the result of progressive fluid accumulation, current European Society of Cardiology (ESC) and American College of Cardiology Foundation/American Heart Association (ACCF/AHA) guidelines recommend a correction of volume status using diuretics, to reduce the total fluid volume. However there is no consensus on how to define fluid overload quantitavely.\n\nIn patients undergoing dialysis, bioelectrical impedance spectroscopy / body composition monitoring (BCM) is a well established tool to assess fluid status, allowing quantitative measurement.\n\nThis study aims to\n\n1. Establish a database reflecting the fluid status assessed by BCM of patients presenting with valvular heart disease according to current guidelines\n2. Monitor fluid status assessed by BCM during increased diuretic treatment in patients presenting with cardiac decompensation due to valvular heart disease\n3. Assess the association between severity of valvular heart disease assessed by echocardiography and/or cardiac magnetic resonance imaging, fluid status assessed by BCM, and clinical as well as laboratory parameters assessed during clinical routine\n4. Assess the relationship between fluid status assessed by BCM and cardiovascular outcome'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients Valvular stenosis and/or regurgitation of all severities assessed by current recommendations are eligible for this study.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Valvular stenosis and/or regurgitation of all severities as defined by current recommendations\n* informed consent\n* willingness to perform follow up visit\n\nExclusion Criteria:\n\n* \\<18 years old\n* pregnancy\n* unwillingness to paricipate'}, 'identificationModule': {'nctId': 'NCT03371394', 'briefTitle': 'Fluid Status in Valvular Heart Disease', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Body Composition Monitoring in Valvular Heart Disease: Association With Clinical Status and Impact on Prognosis', 'orgStudyIdInfo': {'id': 'BCMinVHD-2439'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'median 1', 'interventionNames': ['Other: no intervention']}, {'label': 'median 2', 'interventionNames': ['Other: no intervention']}], 'interventions': [{'name': 'no intervention', 'type': 'OTHER', 'description': 'no intervention', 'armGroupLabels': ['median 1', 'median 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Andreas Kammerlander, MD PhD', 'role': 'CONTACT', 'email': 'andreas.kammerlander@meduniwien.ac.at', 'phone': '004314040046140'}], 'facility': 'Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'centralContacts': [{'name': 'Andreas Kammerlander, MD', 'role': 'CONTACT', 'email': 'andreas.kammerlander@meduniwien.ac.at', 'phone': '004314040046140'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Dr. Andreas Kammerlander', 'investigatorAffiliation': 'Medical University of Vienna'}}}}