Cardiac Dysfunction and Remodeling in Patients With Preeclampsia

Cardiovascular Risk Factor Clinical Trial

— ANGIOCOR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04162236
• Other study ID #: IIBSP-PRE-2019-63
• Status: Recruiting
• Start date: February 1, 2020
• Est. completion date: January 1, 2023

Study information

• Verified date: February 2020
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: Elisa Llurba
• Phone: +0034932919000
• Email: ellurba[@]santpau.cat
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 440
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Risk Factor
• Pre-Eclampsia
• Preeclampsia
• Pregnancy Complications

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (1)

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

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Determine cardiac dysfunction and metabolic status at 12 months after delivery and its correlation with cardiac and preeclampsia risk variables obtained during pregnancy		12 months
Other	To investigate angiogenesis and cardiovascular related genes in placental samples of women with preeclampsia and controls by microarrays and PCR validation.	Placenta will be collected at delivery time and tissue samples will be frozen in liquid N2 and fixed for histology and immunohistochemistry.	1 month
Primary	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.	- Cardiac dysfunction/remodeling in the first and third trimester of pregnancy and in 12 moths after delivery as defined by: abnormal cardiac performace in the ecocardiographyc ultrasound assessment or/and; abnormal biochemical cardiac markers (copectin, proBNP, high-sensitivity troponin)	12 months
Secondary	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	Venous blood will be drawn, with informed consent, from the cubital vein without a tourniquet and using a 20-G needle into Vacutainer CPT	9 months