Heart Failure and Related Risk Factors after Preeclampsia
- Conditions
- Heart failure and Preeclampsia100192801001027310057166
- Registration Number
- NL-OMON54718
- Lead Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 2580
Cases:
• Women aged >= 18 years
• * till 30 years after the complicated pregnancy
• Experienced PE in any pregnancy. PE defined as hypertension (systolic BP >=
140 mmHg and/or diastolic BP >= 90 mmHg) developed after 20 weeks of pregnancy
with the development of proteinuria (>= 300 mg/ 24 hours).
• Women who had their last delivery at least 6 months ago., Controls:
• Women aged >= 18 years
• * till 30 years after the pregnancy that matches the sequence number of
pregnancy of the
specifically matched case.
• Experienced pregnancies that were not complicated by pregnancy induced
hypertension, preeclampsia, HELLP-syndrome, intrauterine growth restriction
and/or abruption placentae.
• Women who had their last pregnancy at least 6 months ago.
Cases: • Women with auto-immune diseases prior to the complicated pregnancy. •
Chronic hypertension prior to the complicated pregnancy. • Renal disease prior
to the complicated pregnancy. • Pregnant women • Women who do not want to be
informed about the results of the tests, or women who do not want their general
practitioner and specialist(s) to be informed about the test results., Control
group: • Women with auto-immune diseases • Chronic hypertension prior to the
matched pregnancy. • Pregnant women • Women who do not want to be informed
about the results of the tests, or women who do not want their general
practitioner and specialist(s) to be informed about the test results. • Women
with IUGR in the matching pregnancy (p<10) • Preterm delivery (gestational
age <37 weeks) • Abruptio placentae in obstetric history
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Main study parameters/endpoints<br /><br>Primary endpoints<br /><br>- The prevalence of HFpEF after PE<br /><br>- Novel biomarker detection in former PE patients associated with HF in general<br /><br>and HFpEF in particular.<br /><br>o Identifying biomarkers that share common pathways for HFpEF and<br /><br>PE or predict the risk of developing HFpEF after PE.<br /><br>o Discovery of diagnostic proteins and miRNAs from extracellular<br /><br>vesicles and circulating cells as well as miRNA from blood samples<br /><br>for HFpEF in women.<br /><br>o Discover responses of plasma to cell functions that are key to<br /><br>vascular endothelial dysfunction using an integrated high content analyses<br /><br>platform and associate the responses with the presence of HFpEF.<br /><br>o Elucidate causal relationship of the potential biomarkers with<br /><br>HFpEF in vitro by linking biomarker analysis to the HFpEF fenotype.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Part I<br /><br>• Lifestyle (questionnaire)<br /><br>• Cognitive ability (questionnaire)<br /><br>• Depression score (questionnaire)<br /><br>• Metabolic syndrome (MetS)<br /><br>• Arterial endothelial function (Flow mediated dilation (FMD))<br /><br>• Intima Media Thickness (IMT)<br /><br>• Glycocalyx thickness (by means of the Glycocheck)<br /><br>• Venous function (plethysmograph)<br /><br>• Electrocardiogram (ECG) Ergometry<br /><br>• Plasma volume measurement<br /><br>• Hemodynamic status by means of Ultrasonic Cardiac Output Monitor (USCOM)<br /><br><br /><br>Part II<br /><br>• Cardiac MRI<br /><br>• Cerebral MRI<br /><br>• Transcranial Doppler measurements<br /><br>• Neurocognitive assessment</p><br>