Sex Related Differences in Cardiac Function

Heart Failure With Preserved Ejection Fraction Clinical Trial

Official title:

Sex Related Differences in Systolic and Diastolic Cardiac Function in Dependence From Lifestyle Modification Factors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05796050
• Other study ID #: 2022-1812
• Status: Recruiting
• Start date: February 2, 2022
• Est. completion date: December 2024

Study information

• Verified date: April 2023
• Source: Heinrich-Heine University, Duesseldorf
• Contact: Lisa Dannenberg, MD
• Phone: +49211811800
• Email: lisa.dannenberg[@]med.uni-duesseldorf.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6000
• Est. completion date: December 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• < 18 years

Related Conditions & MeSH terms

• Diastolic Dysfunction
• Heart Failure With Preserved Ejection Fraction
• Systolic Dysfunction
• Systolic Murmurs

Locations

Country	Name	City	State
Germany	University-Hospital Düsseldorf Division of Cardiology, Pulmonary Disease and Vascular Medicine	Düsseldorf

Sponsors (1)

Lead Sponsor	Collaborator
Heinrich-Heine University, Duesseldorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurence of Heart Failure with preserved ejection fraction	measured by transthoracic echocardiography	3 years
Secondary	Change in ejection fraction	measured by transthoracic echocardiography	3 years
Secondary	Changes in Myocardial strain analysis	measured by transthoracic echocardiography	3 years