Sex Related Differences in Cardiac Function

NCT ID: NCT05796050

Last Updated: 2023-04-05

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 6000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-02
• Study Completion Date: 2024-12-31

Brief Summary

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.

Detailed Description

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.

In 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.

The 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.

Conditions

Heart Failure With Preserved Ejection Fraction; Diastolic Dysfunction; Systolic Dysfunction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Patients who underwent at least one transthoracic echocardiography in between 2019-2022

Exclusion Criteria

• < 18 years

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Malte Kelm, Prof.

Role: STUDY_CHAIR

Clinic for Cardiology, Pneumology and Angiology at University Hospital Düsseldorf

Locations

University-Hospital Düsseldorf Division of Cardiology, Pulmonary Disease and Vascular Medicine

Düsseldorf, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Lisa Dannenberg, MD

Role: CONTACT

lisa.dannenberg@med.uni-duesseldorf.de

+49211811800

Lisa Dannenberg, MD

Role: CONTACT

lisa.dannenberg@med.uni-duesseldorf.de

+492118105315

Facility Contacts

Lisa Dannenberg, MD

Role: primary

lisa.dannenberg@med.uni-duesseldorf.de

+492118105315

Clinical Trial Unit

Role: backup

ctu@med.uni-duesseldorf.de

Other Identifiers

2022-1812

Identifier Type: -

Identifier Source: org_study_id