Clinical Trial: Women Specific Cardiac Recovery After Preeclampsia

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Women Specific Cardiac Recovery After Preeclampsia

Brief Summary: 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.

Detailed Summary:

The main goal of this study is to explore the pattern of physiologic and pathophysiologic cardiac recovery after a preeclamptic pregnancy compared to a normotensive pregnancy, up till 18 months PP.

This study is a longitudinal cohort study. The first measurement will be performed upon admittance for induction of labour or caesarean section, which corresponds with 48-24 hours before delivery. Further measurements will be performed in clusters at PP intervals of: 24-48 hours, 3 weeks, 6 weeks, 3 months, 6 months, 12 months and 18 months. Cases will also receive an additional baseline measurement upon PE diagnosis.

Cases consist of women with preeclampsia (PE) and/or HELLP syndrome in the current pregnancy (early and late PE, with or without intra uterine growth restriction (IUGR)), whereas controls are women with an uncomplicated pregnancy. 290 women in total will be included. Inclusion will of case subjects will occur upon diagnosis, inclusion of controls will occur before delivery.

The first visit of this study will be performed upon admittance after PE diagnosis for cases, and for controls while the participant is administered for the induction of labour or caesarean section, thus an extra visit is not necessary. This is also true for the first postpartum (PP) measurements. The next 6 visits will be after the participant is discharged from the hospital and extra visits are necessary, except for the 6 weeks PP visit, which is a routine visit. The frequent visits may cause some discomfort, especially since our participants are young mothers who still need to take care of their child. During the measurement, one of our co-workers will assist in taking care of the newborn if necessary, so that the participant can bring her child with her. Each of the visits will last approxima
Sponsor: Maastricht University Medical Center

Current Primary Outcome: The pattern of cardiac recovery [ Time Frame: 4 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• The prevalence of abnormal cardiac findings [ Time Frame: 4 years ]
  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).
• Overall health and lifestyle - Metabolic syndrome [ Time Frame: 4 years ]
  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)
• Overall health and lifestyle - Questionnaires [ Time Frame: 4 years ]
  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.
• Overall health and lifestyle - Microcirculation [ Time Frame: 4 years ]
  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.
• Overall health and lifestyle - Kidney function [ Time Frame: 4 years ]
  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.
• VOCs analysis [ Time Frame: 4 years ]
  The highest discriminative pattern of VOCs (Volatile Oxidized Compounds) between PE patients, HELLP syndrome patients, PE + HELLP syndrome patients and healthy control pregnancies.
• FibroScan [ Time Frame: 4 years ]
  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.

Original Secondary Outcome:

• The prevalence of abnormal cardiac findings [ Time Frame: 4 years ]
  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).
• Overall health and lifestyle - Metabolic syndrome [ Time Frame: 4 years ]
  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)
• Overall health and lifestyle - Questionnaires [ Time Frame: 4 years ]
  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.
• Overall health and lifestyle - Microcirculation [ Time Frame: 4 years ]
  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.
• Overall health and lifestyle - Kidney function [ Time Frame: 4 years ]
  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.

Dates:
Date Received: June 8, 2016
Date Started: June 2016
Date Completion: June 2020
Last Updated: December 23, 2016
Last Verified: December 2016