Discovery and validation of diagnostic biomarkers for left ventricular diastolic dysfunction and HEart faiLure with Preserved ejection Fractio
- Conditions
- 10019280Diastolic Heart FailureHeart 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
- 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
• 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
Name Time Method <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
Name Time Method