Ignite Creation Date:
2025-12-26 @ 5:17 PM
Ignite Modification Date:
2026-02-26 @ 3:16 AM
Study NCT ID:
NCT03617406
Status:
COMPLETED
Last Update Posted:
2022-05-17
First Post:
2018-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Volume Challenge Added to DSE in the Diagnosis of Severe LFLGAS
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-16', 'studyFirstSubmitDate': '2018-07-31', 'studyFirstSubmitQcDate': '2018-07-31', 'lastUpdatePostDateStruct': {'date': '2022-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnosis of true severe AS', 'timeFrame': 'Measures taken during echocardiograph a few minutes after administration of VC', 'description': 'Proportion of patients receiving the diagnosis of true severe AS defined as a combination of AVA \\<1.0 cm2 and ∆SV ≥ 20% will be compared between standard LDDSE and LDDSE with addition of VC'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Low - flow', 'Low - gradient', 'Low - dose dobutamine', 'Volume challenge', 'Echocardiography'], 'conditions': ['Aortic Valve Stenosis']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to test the diagnostic added value of Volume Challenge (VC) to low-dose dobutamine stress echocardiography (LDDSE) in patients with a low-flow, low-gradient aortic stenosis (LFLGAS). This study will assess if LDDSE plus VC allows to increase the proportion of patients in whom a true severe AS can be differentiated from a pseudo severe AS.', 'detailedDescription': 'The design of the study is a monocentric prospective non-randomized pilot clinical trial. A standard LDDSE will be performed. The stroke volume (SV) will be recorded. The addition of VC with the passive leg raise method at peak dobutamine dose will be performed. A transesophageal echocardiography (TEE) with low dose dobutamine and a bolus of normal saline will be performed as a validation method to measure AVA with the planimetry method. The SV will be recorded. Proportion of patient receiving the diagnosis of true severe AS defined as a combination of AVA \\<1.0 cm2 and ∆SV ≥ 20% will be compared between standard LDDSE and LDDSE with addition of VC. Calculating sensitivity, specificity, performing ROC curve analysis and calculating the Youden-index, the accuracy of the test method (LDDSE plus passive leg raising) for the detection of truly severe AS in comparison with the reference method (TEE) will be determined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years\n* Written informed consent\n* Patients with LFLGAS (mean Gradient: \\< 40 mmHg, AVA ≤ 1.0 cm2 (by continuity equation using LVOT diameter) SVI ≤ 35 ml/m2), by rest TTE\n\nExclusion Criteria:\n\n* Hypersensitivity to dobutamine or midazolam\n* Lack of safe contraception defined as: Female participants of childbearing potential not using and not willing to continue contraception for study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices.\n* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.,\n* Enrolment of the investigator, his/her family members, employees and other dependent persons\n* Previous enrolment into the current study,\n\nADDITIONAL SPECIFIC EXCLUSION CRITERIA REGARDING STRESS ECHOCARDIOGRAPHY:\n\n* Systolic left ventricular ejection fraction (LVEF) \\< 20%\n* More than mild aortic regurgitation\n* Mitral valve disease, defined by mitral valve area \\< 2.0 cm2 or more than mild mitral regurgitation\n* Unstable angina\n* Acute pulmonary oedema\n* Signs of relevant left ventricular heart failure defined as crackles more than one fourth of lung field on auscultation\n* Signs of relevant right ventricular heart failure defined as central venous pressure (CVP) \\> 15 mmHg estimated with dilatation and collapsibility of vena cava inferior (VCI)\n* Severe pulmonary, renal or hepatic disease\n\nADDITIONAL SPECIFIC EXCLUSION CRITERIA REGARDING TRANSESOPHAGEAL ECHOCARDIOGRAPHY:\n\n* Oesophageal varices\n* History of bariatric surgery'}, 'identificationModule': {'nctId': 'NCT03617406', 'acronym': 'FLOW-AS', 'briefTitle': 'Volume Challenge Added to DSE in the Diagnosis of Severe LFLGAS', 'organization': {'class': 'OTHER', 'fullName': 'Insel Gruppe AG, University Hospital Bern'}, 'officialTitle': 'Volume Challenge Added to Dobutamine Stress Echocardiography in the Diagnosis of Severe Low-Flow, Low-Gradient Aortic Stenosis', 'orgStudyIdInfo': {'id': '3635'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Arm Volume Challenge', 'description': 'A standard LDDSE will be performed. The stroke volume (SV) will be recorded. The addition of VC with the passive leg raise method at peak dobutamine dose will be performed. A TEE with low dose dobutamine and a bolus of normal saline will be performed as a validation method.', 'interventionNames': ['Diagnostic Test: Volume Challenge']}], 'interventions': [{'name': 'Volume Challenge', 'type': 'DIAGNOSTIC_TEST', 'description': 'Addition volume challenge with passive leg raising method in LDDSE as well as administration of normal saline and dobutamine during TEE', 'armGroupLabels': ['Arm Volume Challenge']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'Bern University hospital', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Christian Seiler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Clinic for Cardiology, Inselspital, Bern'}, {'name': 'Stefano de Marchi, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Clinic for Cardiology, Inselspital, Bern'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}