Abstract
BackgroundCardiovascular diseases (CVD) are cause of increased morbidity and mortality in spite of advances for diagnosis and treatment. Changes during pregnancy affect importantly the maternal CV system. Pregnant women that develop preeclampsia (PE) have higher risk (up to 4 times) of clinical CVD in the short- and long-term. Predominance of an anti-angiogenic environment during pregnancy is known as main cause of PE, but its relationship with CV complications is still under research. We hypothesize that angiogenic factors are associated to maternal cardiac dysfunction/remodeling and that these may be detected by new cardiac biomarkers and maternal echocardiography.MethodsProspective cohort study of pregnant women with high-risk of PE in first trimester screening, established diagnosis of PE during gestation, and healthy pregnant women (total intended sample size n = 440). Placental biochemical and biophysical cardiovascular markers will be assessed in the first and third trimesters of pregnancy, along with maternal echocardiographic parameters. Fetal cardiac function at third trimester of pregnancy will be also evaluated and correlated with maternal variables. Maternal cardiac function assessment will be determined 12 months after delivery, and correlation with CV and PE risk variables obtained during pregnancy will be evaluated.DiscussionThe study will contribute to characterize the relationship between anti-angiogenic environment and maternal CV dysfunction/remodeling, during and after pregnancy, as well as its impact on future CVD risk in patients with PE. The ultimate goal is to improve CV health of women with high-risk or previous PE, and thus, reduce the burden of the disease.Trial registrationNCT04162236
Highlights
Cardiovascular diseases (CVD) are cause of increased morbidity and mortality in spite of advances for diagnosis and treatment
Manifestations of CVD, risk factors and treatment are different in women than in men; Ullmo et al BMC Pregnancy and Childbirth (2021) 21:816 women are affected by traditional CVD risk factors, and by gender-specific ones, such as polycystic ovarian syndrome or pregnancy-associated disorders such as preeclampsia (PE) [1]
As history of PE has recently been incorporated by the aforementioned societies as an independent risk factor for CVD [8], follow-up starting within the fourth decade of life is recommended by some authors [9]
Summary
Procedures and interventions Patients will be invited to participate after first trimester screening (11-13+ 6 weeks); once they have consented to the study, a maternal echocardiographic evaluation will be performed, and blood and urine samples will be obtained. Cardiac dysfunction or remodeling in fetuses from mothers at risk for PE or established PE, defined as abnormal cardiac performance in third trimester echocardiographic ultrasound assessment and/ or abnormal cardiac biochemical profile (Copeptin, NT-proBNP, hs-cTnT) in umbilical cord blood at delivery. We will include all pregnant women attending our center for first trimester screening and agreeing to participate in the study They will be divided into two groups according to their PE risk; we plan to include 280 pregnancies with high-risk of PE and 100 patients with low-risk of PE, as well as 60 patients with established PE; we have included an estimated 10% drop-rate during the study. Auditors, Ethics Committee or health authorities, files related to the study will be available upon request
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