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Sex Related Differences in Cardiac Function

Sponsor
Heinrich-Heine University, Duesseldorf (Other)
Overall Status
Recruiting
CT.gov ID
NCT05796050
Collaborator
(none)
6,000
Enrollment
1
Location
33.9
Anticipated Duration (Months)
176.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    6000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Sex Related Differences in Systolic and Diastolic Cardiac Function in Dependence From Lifestyle Modification Factors
    Actual Study Start Date :
    Feb 2, 2022
    Anticipated Primary Completion Date :
    Dec 1, 2023
    Anticipated Study Completion Date :
    Dec 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Occurence of Heart Failure with preserved ejection fraction [3 years]

      measured by transthoracic echocardiography

    Secondary Outcome Measures

    1. Change in ejection fraction [3 years]

      measured by transthoracic echocardiography

    2. Changes in Myocardial strain analysis [3 years]

      measured by transthoracic echocardiography

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients who underwent at least one transthoracic echocardiography in between 2019-2022
    Exclusion Criteria:
    • < 18 years

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University-Hospital Düsseldorf Division of Cardiology, Pulmonary Disease and Vascular Medicine Düsseldorf Germany 40225

    Sponsors and Collaborators

    • Heinrich-Heine University, Duesseldorf

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Heinrich-Heine University, Duesseldorf
    ClinicalTrials.gov Identifier:
    NCT05796050
    Other Study ID Numbers:
    • 2022-1812
    First Posted:
    Apr 3, 2023
    Last Update Posted:
    Apr 5, 2023
    Last Verified:
    Apr 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Heinrich-Heine University, Duesseldorf
    Sex-Related differences cardiovascular disease
    Cardiovascular Disease
    Transthoracic echocardiography
    myocardial strain
    cardiomyopathies
    Additional relevant MeSH terms:
    Systolic Murmurs

    Study Results

    No Results Posted as of Apr 5, 2023