Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2026-01-25 @ 5:55 AM
Study NCT ID:
NCT02883504
Status:
COMPLETED
Last Update Posted:
2016-09-07
First Post:
2016-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation Study of the Accuracy of E/e' in Estimating Left Ventricular Filling Pressure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 85}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'lastUpdateSubmitDate': '2016-09-05', 'studyFirstSubmitDate': '2016-08-22', 'studyFirstSubmitQcDate': '2016-08-24', 'lastUpdatePostDateStruct': {'date': '2016-09-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Invasive evaluation of left ventricular end diastolic pressure', 'timeFrame': 'D0', 'description': 'Left heart catheterization'}], 'secondaryOutcomes': [{'measure': 'Non-invasive evaluation of left ventricular end diastolic pressure', 'timeFrame': 'D0', 'description': 'Echo-Doppler'}]}, 'conditionsModule': {'keywords': ["E/e' ratio", 'Doppler echocardiography, filling pressure', 'Left Ventricular end-Diastolic Pressure'], 'conditions': ['Doppler Echocardiography']}, 'descriptionModule': {'briefSummary': "The non-invasive estimation of left ventricular end diastolic pressure (LVeDP) is a main goal for performing an echocardiography in the routine clinical practice. Conflicting evidence exists about mitral E/e' ratio reliability for predicting high LVeDP"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age over 18 years\n* Patient performing an echocardiography in the routine clinical practice\n* Informed consent given\n\nExclusion Criteria:\n\n* Severe valve disease, valvular prostheses, calcification of the mitral valve, the history of myocardial infarction, atrial fibrillation, severe arrhythmias not allowing the Doppler analysis, pacemaker and any image by inadequate Doppler ultrasound\n* Major person under legal protection (backup justice, trusteeship, guardianship), person deprived of liberty.'}, 'identificationModule': {'nctId': 'NCT02883504', 'acronym': 'EUROFILLING', 'briefTitle': "Validation Study of the Accuracy of E/e' in Estimating Left Ventricular Filling Pressure", 'organization': {'class': 'OTHER', 'fullName': 'Rennes University Hospital'}, 'officialTitle': "Validation Study of the Accuracy of E/e' in Estimating Left Ventricular Filling Pressure", 'orgStudyIdInfo': {'id': '2014-A01331-46'}, 'secondaryIdInfos': [{'id': '35RC14_3003', 'type': 'OTHER', 'domain': 'CHU Rennes'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Echocardiography', 'interventionNames': ['Procedure: Echo-Doppler examination and left heart catheterization']}], 'interventions': [{'name': 'Echo-Doppler examination and left heart catheterization', 'type': 'PROCEDURE', 'armGroupLabels': ['Echocardiography']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rennes', 'country': 'France', 'facility': 'CHU Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}], 'overallOfficials': [{'name': 'Erwan Donal, Md, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CHU Rennes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rennes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}