Sex Related Differences in Cardiac Function

Recruiting

• Conditions: Diastolic Dysfunction; Systolic Dysfunction; Heart Failure With Preserved Ejection Fraction

• Registration Number: NCT05796050
• Lead Sponsor: Heinrich-Heine University, Duesseldorf

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.

Study Timeline

• Study Start: 2022-02-02
• Study First Submitted: 2023-03-21
• Study First Submitted QC: 2023-03-21
• Status Verified: 2023-04
• Study First Posted: 2023-04-03
• Last Update Submitted: 2023-04-03
• Last Update Posted: 2023-04-05
• Primary Completion: 2023-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 6000

Inclusion Criteria

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

Exclusion Criteria

• < 18 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurence of Heart Failure with preserved ejection fraction	3 years	measured by transthoracic echocardiography

Secondary Outcome Measures

Name	Time	Method
Change in ejection fraction	3 years	measured by transthoracic echocardiography
Changes in Myocardial strain analysis	3 years	measured by transthoracic echocardiography

Trial Locations

Locations (1)

University-Hospital Düsseldorf Division of Cardiology, Pulmonary Disease and Vascular Medicine; 🇩🇪 Düsseldorf, Germany