Sex Related Differences in Cardiac Function

April 3, 2023 updated by: Heinrich-Heine University, Duesseldorf

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

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

6000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients that underwent transthoracic echocardiography in the department of Cardiology, Pneumology and Vascular Medicine, University Hospital Düsseldorf.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • < 18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurence of Heart Failure with preserved ejection fraction
Time Frame: 3 years
measured by transthoracic echocardiography
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Myocardial strain analysis
Time Frame: 3 years
measured by transthoracic echocardiography
3 years
Change in ejection fraction
Time Frame: 3 years
measured by transthoracic echocardiography
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heinrich-Heine University, Duesseldorf

Investigators

  • Study Chair: Malte Kelm, Prof., Clinic for Cardiology, Pneumology and Angiology at University Hospital Düsseldorf

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2022

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

March 21, 2023

First Submitted That Met QC Criteria

March 21, 2023

First Posted (Actual)

April 3, 2023

Study Record Updates

Last Update Posted (Actual)

April 5, 2023

Last Update Submitted That Met QC Criteria

April 3, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-1812

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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