Ignite Creation Date:
2025-12-24 @ 8:02 PM
Ignite Modification Date:
2026-04-04 @ 10:11 PM
Study NCT ID:
NCT02727504
Status:
COMPLETED
Last Update Posted:
2020-02-07
First Post:
2016-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low Flow Low Gradient Aortic Stenosis Relevance of the (re)Search for a Contractile Reserve
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004562', 'term': 'Electrocardiography'}, {'id': 'D019560', 'term': 'Echocardiography, Three-Dimensional'}, {'id': 'D025401', 'term': 'Echocardiography, Stress'}, {'id': 'D006403', 'term': 'Hematologic Tests'}], 'ancestors': [{'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004568', 'term': 'Electrodiagnosis'}, {'id': 'D004452', 'term': 'Echocardiography'}, {'id': 'D057791', 'term': 'Cardiac Imaging Techniques'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D021621', 'term': 'Imaging, Three-Dimensional'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-06', 'studyFirstSubmitDate': '2016-03-21', 'studyFirstSubmitQcDate': '2016-03-29', 'lastUpdatePostDateStruct': {'date': '2020-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of death of all cause', 'timeFrame': 'Month 12'}, {'measure': 'Number of emergent hospitalization for any cardiovascular reason', 'timeFrame': 'Month 12'}], 'secondaryOutcomes': [{'measure': 'Death (all causes)', 'timeFrame': '12 months'}, {'measure': 'Emergency Cardiovascular hospitalization', 'timeFrame': '12 months'}, {'measure': 'Change in left ventricular ejection fraction (LVEF), in global longitudinal strain in 2D and or 3D echocardiography', 'timeFrame': 'Inclusion, 12 months'}, {'measure': 'Symptoms evolution', 'timeFrame': 'Inclusion, 12 months', 'description': '6-minute walking test'}, {'measure': 'Symptoms evolution', 'timeFrame': 'Inclusion, 12 months', 'description': 'Duke Activity Score'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Aortic valve stenosis', 'low flow', 'dobutamine stress echocardiography'], 'conditions': ['Aortic Valve Stenosis']}, 'descriptionModule': {'briefSummary': 'Investigators sought to demonstrate that the increase in the stroke volume during a dobutamine stress echocardiography might impact the prognosis of a patient addressed for a low flow low gradient suspected severe aortic valve stenosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '45 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with low flow low gradient aortic stenosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient from 45 to 90 years old\n* Patient agreeing freely to participate in the study\n* Aortic surface area suspected to be \\< 1 cm² or \\< 0.6 cms²/m²\n* Low aortic gradient defined by a mean pressure gradient \\< 40 mmHg\n* Aortic low flow defined by: a stroke volume indexed \\< 35 ml/m2\n* Any contra-indication for the realization of the MRI\n\nExclusion Criteria:\n\n* Heart rhythm disorders\n* Presence of comorbidity altering the 2-year prognosis of a patient (cancer, terminal renal insufficiency (GFR 30 ml / min / 1,73m2), liver cirrhosis, respiratory insufficiency (VEMS 1 L)\n* Presence of a concomitant valvular heart disease with stenosis or regurgitation \\> moderated\n* Persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty'}, 'identificationModule': {'nctId': 'NCT02727504', 'acronym': 'LOWAS', 'briefTitle': 'Low Flow Low Gradient Aortic Stenosis Relevance of the (re)Search for a Contractile Reserve', 'organization': {'class': 'OTHER', 'fullName': 'Rennes University Hospital'}, 'officialTitle': 'Low Flow Low Gradient Aortic Stenosis Relevance of the (re)Search for a Contractile Reserve', 'orgStudyIdInfo': {'id': '2015-A00896-43'}, 'secondaryIdInfos': [{'id': '35RC15_9884_LOWAS', 'type': 'OTHER', 'domain': 'CHU de Rennes'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient with aortic valve stenosis', 'description': '115 patients will undergo a medical examination in order to analyse their medical history, cardiovascular parameters and check inclusion and non-inclusion criterions.\n\nThen will be performed :\n\n* An electrocardiogram\n* 2D and 3D echocardiography\n* Dobutamine stress echocardiography\n* Blood tests : blood electrolytes, creatinine, hemoglobin, N-terminal pro-brain natriuretic peptide (NT-ProBNP), C reactive protein (CRP), soluble suppression of tumorigenicity-2 (ST-2)\n* A cardiac MRI\n* A cardiac scanner\n* A 6-minutes walking test\n* An evolution of the Duke Activity Score', 'interventionNames': ['Device: Electrocardiogram', 'Device: 2D and 3D echocardiography', 'Device: Dobutamine stress echocardiography', 'Biological: Blood tests', 'Device: Cardiac MRI', 'Device: Cardiac scanner', 'Other: 6-minutes walking test', 'Other: Duke Activity Score']}], 'interventions': [{'name': 'Electrocardiogram', 'type': 'DEVICE', 'description': 'ECG at inclusion and M12', 'armGroupLabels': ['Patient with aortic valve stenosis']}, {'name': '2D and 3D echocardiography', 'type': 'DEVICE', 'description': '2D and 3D echocardiography at inclusion and M12', 'armGroupLabels': ['Patient with aortic valve stenosis']}, {'name': 'Dobutamine stress echocardiography', 'type': 'DEVICE', 'description': 'dobutamine stress echocardiography at inclusion', 'armGroupLabels': ['Patient with aortic valve stenosis']}, {'name': 'Blood tests', 'type': 'BIOLOGICAL', 'description': 'Blood test electrolytes, creatinine, hemoglobin, NT-proBNP, CRP, ST-2 at inclusion and M12', 'armGroupLabels': ['Patient with aortic valve stenosis']}, {'name': 'Cardiac MRI', 'type': 'DEVICE', 'description': 'Cardiac MRI at inclusion', 'armGroupLabels': ['Patient with aortic valve stenosis']}, {'name': 'Cardiac scanner', 'type': 'DEVICE', 'description': 'Cardiac scanner at inclusion', 'armGroupLabels': ['Patient with aortic valve stenosis']}, {'name': '6-minutes walking test', 'type': 'OTHER', 'description': '6-minutes walking test at inclusion and M12', 'armGroupLabels': ['Patient with aortic valve stenosis']}, {'name': 'Duke Activity Score', 'type': 'OTHER', 'description': 'Duke Activity Score at inclusion and M12', 'armGroupLabels': ['Patient with aortic valve stenosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35033', 'city': 'Rennes', 'country': 'France', 'facility': 'CHU de Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rennes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}