MedPath

Discovery and validation of diagnostic biomarkers for left ventricular diastolic dysfunction and HEart faiLure with Preserved ejection Fractio

Completed
Conditions
10019280
Diastolic Heart Failure
Heart failure with preserved ejection fraction
Registration Number
NL-OMON50536
Lead Sponsor
niversitair Medisch Centrum Utrecht
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
977
Inclusion Criteria

- Patients in the cardiology outpatient clinic of Cardiology Centre
Netherlands, Diakonessenhuis Utrecht or HeartLife Klinieken Utrecht who
receive cardial screening, including an echocardiography, because of general
practitioner*s request
- Age 45 year and older
- Patient is willing and able to provide written informed consent for
participation in this study
- The inclusion criteria match the criteria for diagnosis of diastolic
dysfunction or HFpEF., Additional ARGUS, Inclusion criteria ARGUS
In order to be eligible to participate in the ARGUS study, a subject must meet
the additional following criterium:
• Chest pain as main symptom

Exclusion Criteria

• Patients from whom no informed consent is obtained
• Incapacitated adults: language barriers or other obstacles for full
understanding of the study objectives
• Patients with former cardiac procedures.
• Patients with congenital heart disease,

Additional ARGUS:
A potential subject who meets any of the mentioned criteria or any of the
following will be excluded from participation in the ARGUS study:
• Patients for whom (a part of) the cardiac CT study protocol is contra
indicated prior to inclusion (if CT is contra indicated after completion of
MRI-scan patient will not be excluded but collected data will be used in study)
• Patients for whom (a part of) the cardiac MRI study protocol is contra
indicated prior to inclusion (if MRI is contra indicated after completion of
CT-scan patient will not be excluded but collected data will be used in study)
• Participants who are referred for an intervention immediately after
completing the cardiac CT scan

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Our primary aim is to improve the (early) diagnosis of diastolic dysfunction<br /><br>and HFPEF with the discovery and validation of new biomarkers. Since HFPEF is<br /><br>more prevalent in females, we will focus on discovery of sex-specific<br /><br>biomarkers..<br /><br><br /><br>Endpoint: diagnosis of grade of diastolic dysfunction (LVDD) confirmed by E/e*<br /><br>values or HFpEF<br /><br><br /><br>Additioneel ARGUS:<br /><br>To describe the prevalence of CAD and coronary microvascular disease (CMD) in a<br /><br>population of patients from the general population who are referred to the<br /><br>Cardiology Center Netherlands, location Utrecht or the Diakonessenhuis by their<br /><br>general practitioner and present with chest pain as the main symptom. </p><br>
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath