NCT05796050

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
6,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 2, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 21, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 3, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

April 5, 2023

Status Verified

April 1, 2023

Enrollment Period

1.8 years

First QC Date

March 21, 2023

Last Update Submit

April 3, 2023

Conditions

Heart Failure With Preserved Ejection FractionDiastolic DysfunctionSystolic Dysfunction

Keywords

Sex-Related differences cardiovascular diseaseCardiovascular DiseaseTransthoracic echocardiographymyocardial straincardiomyopathies

Outcome Measures

Primary Outcomes (1)

  • Occurence of Heart Failure with preserved ejection fraction

    measured by transthoracic echocardiography

    3 years

Secondary Outcomes (2)

  • Change in ejection fraction

    3 years

  • Changes in Myocardial strain analysis

    3 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • \< 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University-Hospital Düsseldorf Division of Cardiology, Pulmonary Disease and Vascular Medicine

Düsseldorf, 40225, Germany

RECRUITING

MeSH Terms

Conditions

Cardiovascular DiseasesCardiomyopathies

Condition Hierarchy (Ancestors)

Heart Diseases

Study Officials

  • Malte Kelm, Prof.

    Clinic for Cardiology, Pneumology and Angiology at University Hospital Düsseldorf

    STUDY CHAIR

Central Study Contacts

Lisa Dannenberg, MD

CONTACT

+49211811800lisa.dannenberg@med.uni-duesseldorf.de

Lisa Dannenberg, MD

CONTACT

+492118105315lisa.dannenberg@med.uni-duesseldorf.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2023

First Posted

April 3, 2023

Study Start

February 2, 2022

Primary Completion

December 1, 2023

Study Completion

December 1, 2024

Last Updated

April 5, 2023

Record last verified: 2023-04

Locations

DE(1)