NCT04162236

Cardiac Dysfunction and Remodeling in Patients With Preeclampsia

Cardiac Dysfunction and Remodeling in Patients With Preeclampsia Regulated by Antiangiogenic Environment: Clinical and Experimental Approach

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 440 (estimated)
• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Preeclampsia (PE) is a pregnancy-related hypertensive disorder drive by an anti-angiogenic environment. Women with PE have 2-4 time higher risk of developing cardiovascular disease (CVD), although the specific mechanism relating these two conditions remains elusive. In non-pregnant patients with coronary disease, angiogenic profile proved to be an independent predictor of poor prognosis and is associated with a higher mortality rate. The investigators hypothesized that in PE, the antiangiogenic environment determines the degree of cardiac dysfunction and remodeling and the posterior cardiovascular risk.

Detailed description

Main objective: To determinie the relationship between antiangiogenic environment and cardioc dysfuntion and remodelin in women at risk and in established PE. M\&M: placental dysfunction markers (angiogenic factors (PlGF) and anti-angiogenic factor (sFlt1) and cardiovascular risk variables (BMI, BP, arterial stiffness, copectin, proBNP, high-sensitivity troponin, carotid intima thickness and echocardiography parameters) would be evaluated in 280 patients at risk of PE according to first trimester screening and 100 controls. Additionally, cardiac dysfunction parameters would be evaluated in women with established PE (n=60) and common transcriptomic signatures between cardiovascular disease and preeclampsia would be investigated in placental samples from 10 PE and 10 controls. It will provide evidences to evaluate and characterize the association between angiogenic factors and cardiac dysfunction and remodeling in PE.

Conditions

• Preeclampsia
• Cardiovascular Risk Factor
• Pregnancy Complications

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Ecocardiographyc ultrasound	* Epidemiological data: Maternal history risk factors. First trimester scan is performed on all patients. * Antropomethric measures * Systemic arterial stiffness: using applanation tonometry with pulse wave analysis and pulse wave velocity. * Carotid Intima Thickness * Echocardiography assessment: It will be performed by a cardiologist specialized in cardiac imaging according to the usual standard protocol. High resolution images will be acquired and post-processed with dedicated software for the speckle tracking analysis. 2D echocardiography parameters to be acquired, tissue Doppler and speckle tracking software * Markers in maternal blood: Angiogenic factor and cardiac function biomarkers: Blood samples will be collected without anticoagulant to obtain serum. sFLT-1, PlGF, High-sensitivity Troponin and NT-proBNP will be measured using automated electrochemiluminescence immunoassays.

Timeline

• Start date: 2020-02-01
• Primary completion: 2022-01-01
• Completion: 2023-01-01
• First posted: 2019-11-14
• Last updated: 2020-02-13

Locations

1 site across 1 country: Spain