Pregnancy Clinical Trial
— WeCareOfficial title:
Women Specific Cardiac Recovery After Preeclampsia
Pregnancy is considered a cardiovascular (CV) stress test, and complicated pregnancies are associated with an increased risk for cardiovascular disease (CVD) later in life. Moreover, it is known that often the pregnancy induced CV adaptation does not resolve completely after a short postpartum (PP) period and it is not clear whether these induced changes will resolve over a longer period of time (i.e. in the upcoming months/years after delivery). Understanding the cardiac adaptation during pregnancy and the reversal process in the postpartum period, as well as the factors that influence this these processes, may provide us not only insight in this mechanism, but may help us in identifying factors that may be target points for modification.
Status | Recruiting |
Enrollment | 290 |
Est. completion date | June 2022 |
Est. primary completion date | June 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Women aged = 18 years - Controls: Women with an uncomplicated pregnancy at the moment of inclusion (i.e no foetal or maternal placental complications, such as pregnancy induced hypertension, preeclampsia or HELLP-syndrome, or small for gestational birth infancies) - Cases: Women diagnosed with a preeclamptic pregnancy at the moment of inclusion Exclusion Criteria: - Women with an auto-immune disease prior to the complicated pregnancy - Chronic hypertension prior to the complicated pregnancy - Renal disease prior to the complicated pregnancy - 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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | Maastricht University Medical Center (MUMC+) | Maastricht |
Lead Sponsor | Collaborator |
---|---|
Maastricht University Medical Center |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The pattern of cardiac recovery | The pattern of cardiac recovery in terms of cardiac geometry (measured by relative wall thickness, left ventricular mass and cardiac dimension such as LV end systolic and diastolic diameters, atrial diameters etc..), systolic and diastolic function (measured by ejection fraction (EF%) and E/A ratio) and miRNA expression after a preeclamptic pregnancy compared to a normotensive pregnancy | 4 years | |
Secondary | The prevalence of abnormal cardiac findings | The prevalence of abnormal cardiac findings amongst participants, such as, Concentric remodeling (based on relative wall thickness (RWT) and LVmass (gr/m2)), left ventricular (LV) hypertrophy (based on LVmass (gr/m2)), LV segmental myocardial impaired relaxation, LV segmental myocardial impaired contractility, Global systolic and diastolic dysfunction (based on ejection fraction (%) and E/A ratio respectively). | 4 years | |
Secondary | Overall health and lifestyle - Metabolic syndrome | The number of participants with metabolic syndrome (MetS). The MetS is a cluster of risk factors which consists of cardio-metabolic abnormalities (insulin resistance and/or impaired glucose tolerance, low high density lipoprotein (HDL) cholesterol, high triglycerides (TG)) and cardiovascular mechanical stress indicators (elevated BP, micro albuminuria, obesity). We will define the MetS based on The World Health Organisation (WHO) criteria. It consists of impaired glucose regulation, diabetes mellitus or insulin resistance with at least two of the following criteria: Elevated TG (=1.7 nmol/l) or reduced HDL-cholesterol (< 1.0 mmol/l),Elevated BP (=140/85mmHg), Central obesity (waist-hip ratio > 0.85 or BMI > 30 kg/m2), Micro-albuminuria (> 0.30 g/mmol creatinine) | 4 years | |
Secondary | Overall health and lifestyle - Questionnaires | The prevalence of cardiovascular risk factors amongst participants (determined via questionnaires).The questionnaires contains questions about daily exercise, eating and drinking habits (mainly the consumption of fruits and vegetables), and smoking/alcohol/drugs consumption. Lifestyle is known to affect the risk for CVD.By exploring lifestyle factors in both subjects and controls, we will be able to determine the (confounding) contributio of lifestyle factors for the increased risk of CVD after PE. Consequently, we will be able to study the contribution of PE independent of lifestyle on the development of CVD. | 4 years | |
Secondary | Overall health and lifestyle - Microcirculation | The number of participants with an increased perfused boundary region (PBR), as measures with Glycocheck. The main read-out parameter of the glycocheck machine is the perfused boundary region (PBR). In short, the endothelial glycocalyx constitutes a protective barrier for the vessel wall, which limits the proximity of erythrocytes to the endothelial cells in the microvasculature, causing the PBR to be small in healthy conditions. In contrast, perturbation of the glycocalyx allows deeper cell penetration into the glycocalyx, leading to an increase in PBR. Monitoring of the PBR, therefore, gives information about the barrier properties of the glycocalyx and the state of the microvascular system. | 4 years | |
Secondary | Overall health and lifestyle - Kidney function | The number of participants with a decreased kidney function, measured by abnormal lab values of a urine sample, such as total protein, creatinine and micro-albumin. | 4 years | |
Secondary | VOCs analysis | The highest discriminative pattern of VOCs (Volatile Oxidized Compounds) between PE patients, HELLP syndrome patients, PE + HELLP syndrome patients and healthy control pregnancies. | 4 years | |
Secondary | FibroScan | Differences in metabolism, liver stiffness, fibrosis and steatosis of the liver between PE patients, HELLP syndrome patients, PE + HELLP syndrome patients and healthy control pregnancies at the time of diagnosis and over time. | 4 years |
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