Clinical trial NCT05796050: Sex Related Differences in Cardiac Function
Official title: Sex Related Differences in Systolic and Diastolic Cardiac Function in Dependence From Lifestyle Modification Factors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure With Preserved Ejection Fraction
Diastolic Dysfunction
Systolic Dysfunction
Keywords: Sex-Related differences cardiovascular disease
Cardiovascular Disease
Transthoracic echocardiography
myocardial strain
cardiomyopathies
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2023-04-03
Enrollment: 6000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that underwent transthoracic echocardiography in the department of Cardiology, Pneumology and Vascular Medicine, University Hospital Düsseldorf.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* \< 18 years

Primary outcomes:
measure: Occurence of Heart Failure with preserved ejection fraction
timeFrame: 3 years
Secondary outcomes:
measure: Change in ejection fraction
timeFrame: 3 years
measure: Changes in Myocardial strain analysis
timeFrame: 3 years
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: University-Hospital Düsseldorf Division of Cardiology, Pulmonary Disease and Vascular Medicine
Study officials:
affiliation: Clinic for Cardiology, Pneumology and Angiology at University Hospital Düsseldorf
name: Malte Kelm, Prof.
role: STUDY_CHAIR
References: