Heart failure and Preeclampsia
Conditions
Interventions
None listed
Sponsors
Medisch Universitair Ziekenhuis Maastricht
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameters/endpoints Primary endpoints - The prevalence of HFpEF after PE - Novel biomarker detection in former PE patients associated with HF in general and HFpEF in particular. o Identifying biomarkers that share common pathways for HFpEF and PE or predict the risk of developing HFpEF after PE. o Discovery of diagnostic proteins and miRNAs from extracellular vesicles and circulating cells as well as miRNA from blood samples for HFpEF in women. o Discover responses of plasma to cell functions that are key to vascular endothelial dysfunction using an integrated high content analyses platform and associate the responses with the presence of HFpEF. o Elucidate causal relationship of the potential biomarkers with HFpEF in vitro by linking biomarker analysis to the HFpEF fenotype. | — |
Secondary
| Measure | Time frame |
|---|---|
| Part I • Lifestyle (questionnaire) • Cognitive ability (questionnaire) • Depression score (questionnaire) • Metabolic syndrome (MetS) • Arterial endothelial function (Flow mediated dilation (FMD)) • Intima Media Thickness (IMT) • Glycocalyx thickness (by means of the Glycocheck) • Venous function (plethysmograph) • Electrocardiogram (ECG) Ergometry • Plasma volume measurement • Hemodynamic status by means of Ultrasonic Cardiac Output Monitor (USCOM) Part II • Cardiac MRI • Cerebral MRI • Transcranial Doppler measurements • Neurocognitive assessment | — |
Countries
Netherlands
Outcome results
None listed