Cardiac Dysfunction and Remodeling in Patients With Preeclampsia (ANGIOCOR)

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Status: Unknown

Conditions: Pregnancy Complications; Preeclampsia; Cardiovascular Risk Factor

Treatments: Diagnostic Test: Ecocardiographyc ultrasound

Study type: Observational

Funder types: Other

Identifiers

NCT04162236

IIBSP-PRE-2019-63

Details and patient eligibility

About

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.

Full 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.

Enrollment: 440 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

440 participants in 3 patient groups

High Risk of Preeclampsia

Description:

Women with a singleton pregnancies attending for prenatal care in the maternal and fetal Medicine Unit will be asked to participate if they meet the following criteria: 1)High risk for preeclampsia according to first trimester screening (maternal risk factors, blood preassure, PPAP-A, mean pulsatility index (PIm) of the uterine arteries (UtA) at 11.0 to 13.6 weeks of gestation (n=280). Women in this group will be subdivided in cases and controls according to the later development of preeclampsia: * cases: women developing PE (estimated n=40) * controls: women not developing PE (estimated n=240)

Treatment:

Diagnostic Test: Ecocardiographyc ultrasound

Patients with Preeclampsia

Description:

Women with a singleton pregnancies attending for prenatal care in the maternal and fetal Medicine Unit will be asked to participate if they develop PE. Inclusion criteria: Patients presented with clinical signs and symptoms of preeclampsia (N=60).

Treatment:

Diagnostic Test: Ecocardiographyc ultrasound

Control group

Description:

Healthy pregnant women with at low risk PE screening at 11.0 to 13.6 weeks of gestation (n=100).

Treatment:

Diagnostic Test: Ecocardiographyc ultrasound