Cardiac Dysfunction and Remodeling in Patients With Preeclampsia

• Conditions: Preeclampsia; Cardiovascular Risk Factor; Pregnancy Complications

• Registration Number: NCT04162236
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Brief 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.

Study Timeline

• Study First Submitted: 2019-11-11
• Study First Submitted QC: 2019-11-11
• Study First Posted: 2019-11-14
• Status Verified: 2020-02
• Study Start: 2020-02-01
• Last Update Submitted: 2020-02-11
• Last Update Posted: 2020-02-13
• Primary Completion: 2022-01-01
• Study Completion: 2023-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 440

Inclusion Criteria

1. >18 and <45 years old.
2. Able to understand the study requirements.
3. Singleton pregnancy.
4. Accept of written informed consent.

Exclusion Criteria

1. <18 or >45 years old.
2. Not able to understand the study requirements.
3. Multiple pregnancy.
4. Previous conditions: abnormal thrombophilia, alcohol or illicit drug use, type-1 diabetes, hyperthyroidism, renal disease, severe maternal illness, cytomegalovirus or toxoplasma infection, maternal HIV infection, , previous venous or arterial thrombotic event, and
5. known major fetal anomaly or chromosomal abnormality at inclusion
6. denial of written informed consent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To prospectively assess both biochemical and biophysical markers of cardiovascular dysfunction in a cohort of patients with a risk of pe and in healthy pregnant women in the fisrt and third trimester of pregnancy.	12 months	- Cardiac dysfunction/remodeling in the first and third trimester of pregnancy and in 12 moths after delivery as defined by: 1. abnormal cardiac performace in the ecocardiographyc ultrasound assessment or/and; 2. abnormal biochemical cardiac markers (copectin, proBNP, high-sensitivity troponin)

Secondary Outcome Measures

Name	Time	Method
To determine the correlation among antiogenic (PlGF) and anti-angiogenic factors (sFlt1) in maternal serum and biochemical and imaging markers of cardiac dysfunction and remodeling in patients with established PE AND	9 months	Venous blood will be drawn, with informed consent, from the cubital vein without a tourniquet and using a 20-G needle into Vacutainer CPT

Trial Locations

Locations (1)

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain