Ignite Creation Date:
2025-12-25 @ 2:26 AM
Ignite Modification Date:
2026-04-18 @ 6:24 AM
Study NCT ID:
NCT03154034
Status:
COMPLETED
Last Update Posted:
2021-10-11
First Post:
2017-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiopulmonary Exercise Testing in Severe Mitral Regurgitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008944', 'term': 'Mitral Valve Insufficiency'}, {'id': 'D006976', 'term': 'Hypertension, Pulmonary'}], 'ancestors': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood (serum and plasma samples)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-08', 'studyFirstSubmitDate': '2017-05-10', 'studyFirstSubmitQcDate': '2017-05-12', 'lastUpdatePostDateStruct': {'date': '2021-10-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'exercise-induced systolic pulmonary arterial pressure', 'timeFrame': 'Change from Baseline Exercise-Induced Systolic Pulmonary Arterial Pressure at 1 year', 'description': 'exercise-induced systolic pulmonary arterial pressure measured by stress- echocardiography'}], 'secondaryOutcomes': [{'measure': 'peak oxygen uptake (peakVO2)', 'timeFrame': 'Change from Baseline peakVO2 at 1 year', 'description': 'peak oxygen uptake measured by ergospirometry'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stress echocardiography', 'Cardiopulmonary exercise testing', 'ergospirometry'], 'conditions': ['Mitral Valve Regurgitation', 'Pulmonary Hypertension']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is the evaluation of cardiac and pulmonary response to cardiopulmonary exercise in severe mitral regurgitation and its variation under treatment (surgical mitral valve repair, percutaneous mitral valve repair, optimal medical treatment). The study is conducted as a prospective, observational, single-center study. Patients suffering from symptomatic severe mitral regurgitation will be eligible, if they are referred to the University Hospital of Regensburg, Germany, for further diagnostic procedures and heart team discussion. Cardiopulmonary exercise testing is performed comprising standardized stress echocardiography as well as ergospirometry. Additional detailed assessment will be conducted including standardized questionary, clinical examination, transesophageal echocardiography and measurement of biomarkers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Symptomatic, severe mitral regurgitation. Aetiology and treatment of mitral regurgitation do not affect enrollment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* symptomatic, severe mitral regurgitation\n* referral for diagnostic work-up and heart team discussion\n* declaration of informed consent\n\nExclusion Criteria:\n\n* contra-indication for cardiopulmonary stress examination (unstable angina pectoris, left main disease, abnormal electrolyte concentrations, acute decompensation)\n* pregnancy\n* exercise test on treadmill not possible (amputation of lower extremity, severe arthritis of lower extremities)\n* no acceptable acoustic window at rest'}, 'identificationModule': {'nctId': 'NCT03154034', 'briefTitle': 'Cardiopulmonary Exercise Testing in Severe Mitral Regurgitation', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Regensburg'}, 'officialTitle': 'Cardiopulmonary Exercise Testing in Severe Mitral Regurgitation - a Single Center, Observational Echocardiographic Study', 'orgStudyIdInfo': {'id': 'UHRegensburg1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Severe mitral regurgitation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '93053', 'city': 'Regensburg', 'country': 'Germany', 'facility': 'University Hospital Regensburg - Department of Internal Medicine II', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}], 'overallOfficials': [{'name': 'Alexander Dietl, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Regensburg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Regensburg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident', 'investigatorFullName': 'Dr. Alexander Dietl', 'investigatorAffiliation': 'University Hospital Regensburg'}}}}