Ignite Creation Date:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2025-12-30 @ 3:24 AM
Study NCT ID:
NCT05796050
Status:
UNKNOWN
Last Update Posted:
2023-04-05
First Post:
2023-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sex Related Differences in Cardiac Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009202', 'term': 'Cardiomyopathies'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-03', 'studyFirstSubmitDate': '2023-03-21', 'studyFirstSubmitQcDate': '2023-03-21', 'lastUpdatePostDateStruct': {'date': '2023-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurence of Heart Failure with preserved ejection fraction', 'timeFrame': '3 years', 'description': 'measured by transthoracic echocardiography'}], 'secondaryOutcomes': [{'measure': 'Change in ejection fraction', 'timeFrame': '3 years', 'description': 'measured by transthoracic echocardiography'}, {'measure': 'Changes in Myocardial strain analysis', 'timeFrame': '3 years', 'description': 'measured by transthoracic echocardiography'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sex-Related differences cardiovascular disease', 'Cardiovascular Disease', 'Transthoracic echocardiography', 'myocardial strain', 'cardiomyopathies'], 'conditions': ['Heart Failure With Preserved Ejection Fraction', 'Diastolic Dysfunction', 'Systolic Dysfunction']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to investigate sex-specific differences in LV and RV function (systolic and diastolic) with regarding the development and progression of heart failure with preserved ejection fraction based on a retrospective data analysis. Lifestyle modification factors will be assessed for multivariate analyses in order to detect influencing factors. Progression will be analysed in a retrospective time series analysis.', 'detailedDescription': 'Compared to men, women show a different cardiovascular risk profile, In this context, it has already been shown that mortality in women with cardiovascular diseases is increased. Along with this, there are first indications of an echocardiographic altered cardiac function. It was shown that women are more prone to heart failure with preserved ejection fraction. However, the underlying mechanisms and driving factors have not yet been fully explored. Moreover, the role of associated factors such as smoking, bodyweight or cardiovascular risk factors and menopause status remain nut fully understood.\n\nIn this project differences differences in sex-specific LV and RV function depending on defined risk factors will be investigated. For this purpose, a retrospective follow-up analysis willl be carried out. This is based on test results from patients who underwent transthoracic echocardiography in the echocardiography department of the Department of Cardiology, Pneumology and Angiology University Hospital Düsseldorf.\n\nThe aim is to evaluate possible differences in the sex-specific risk profile. This may allow us to define the cardiovascular risk profile in dependence from each sex more concretely.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients that underwent transthoracic echocardiography in the department of Cardiology, Pneumology and Vascular Medicine, University Hospital Düsseldorf.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who underwent at least one transthoracic echocardiography in between 2019-2022\n\nExclusion Criteria:\n\n* \\< 18 years'}, 'identificationModule': {'nctId': 'NCT05796050', 'briefTitle': 'Sex Related Differences in Cardiac Function', 'organization': {'class': 'OTHER', 'fullName': 'Heinrich-Heine University, Duesseldorf'}, 'officialTitle': 'Sex Related Differences in Systolic and Diastolic Cardiac Function in Dependence From Lifestyle Modification Factors', 'orgStudyIdInfo': {'id': '2022-1812'}}, 'contactsLocationsModule': {'locations': [{'zip': '40225', 'city': 'Düsseldorf', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Lisa Dannenberg, MD', 'role': 'CONTACT', 'email': 'lisa.dannenberg@med.uni-duesseldorf.de', 'phone': '+492118105315'}, {'name': 'Clinical Trial Unit', 'role': 'CONTACT', 'email': 'ctu@med.uni-duesseldorf.de'}], 'facility': 'University-Hospital Düsseldorf Division of Cardiology, Pulmonary Disease and Vascular Medicine', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}], 'centralContacts': [{'name': 'Lisa Dannenberg, MD', 'role': 'CONTACT', 'email': 'lisa.dannenberg@med.uni-duesseldorf.de', 'phone': '+49211811800'}, {'name': 'Lisa Dannenberg, MD', 'role': 'CONTACT', 'email': 'lisa.dannenberg@med.uni-duesseldorf.de', 'phone': '+492118105315'}], 'overallOfficials': [{'name': 'Malte Kelm, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Clinic for Cardiology, Pneumology and Angiology at University Hospital Düsseldorf'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heinrich-Heine University, Duesseldorf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}