Clinical trial NCT04162236: Cardiac Dysfunction and Remodeling in Patients With Preeclampsia
Official title: Cardiac Dysfunction and Remodeling in Patients With Preeclampsia Regulated by Antiangiogenic Environment: Clinical and Experimental Approach
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Preeclampsia
Cardiovascular Risk Factor
Pregnancy Complications
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2019-11-14
Enrollment: 440
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women at high risk of \<preeclampsia on first trimestre scan

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 12 months
Secondary outcomes:
measure: 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
timeFrame: 9 months
Other outcomes:
measure: Determine cardiac dysfunction and metabolic status at 12 months after delivery and its correlation with cardiac and preeclampsia risk variables obtained during pregnancy
timeFrame: 12 months
measure: To investigate angiogenesis and cardiovascular related genes in placental samples of women with preeclampsia and controls by microarrays and PCR validation.
timeFrame: 1 month
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
affiliation: Institut de Recerca Hospital de la Santa Creu i Sant Pau
name: Elisa Llurba
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ullmo J, Cruz-Lemini M, Sanchez-Garcia O, Bos-Real L, Fernandez De La Llama P, Calero F, Dominguez-Gallardo C, Garrido-Gimenez C, Trilla C, Carreras-Costa F, Sionis A, Mora J, Garcia-Osuna A, Ordonez-Llanos J, Llurba E. Cardiac dysfunction and remodeling regulated by anti-angiogenic environment in patients with preeclampsia: the ANGIOCOR prospective cohort study protocol. BMC Pregnancy Childbirth. 2021 Dec 8;21(1):816. doi: 10.1186/s12884-021-04263-w.