Cardiac Dysfunction and Remodeling in Patients With Preeclampsia

NCT04162236 | Unknown

• 1 other identifier: IIBSP-PRE-2019-63
• Study Type: observational
• Target: 440
• Locations: 1 country
• Sites: 1

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.

Conditions

Preeclampsia; Cardiovascular Risk Factor; Pregnancy Complications

Outcome Measures

Primary Outcomes (1)

• 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: 1. abnormal cardiac performace in the ecocardiographyc ultrasound assessment or/and 2. abnormal biochemical cardiac markers (copectin, proBNP, high-sensitivity troponin)

  12 months

Secondary Outcomes (1)

• 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

Other Outcomes (2)

• 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

• To investigate angiogenesis and cardiovascular related genes in placental samples of women with preeclampsia and controls by microarrays and PCR validation.

  1 month

Study Arms (3)

High Risk of Preeclampsia

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)

Diagnostic Test: Ecocardiographyc ultrasound

Patients with Preeclampsia

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).

Diagnostic Test: Ecocardiographyc ultrasound

Control group

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

Diagnostic Test: Ecocardiographyc ultrasound

Interventions

Ecocardiographyc ultrasound DIAGNOSTIC_TEST

* 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.

Also known as: Blood test, Carotid intima thickness

Control group; High Risk of Preeclampsia; Patients with Preeclampsia

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women at high risk of \<preeclampsia on first trimestre scan

You may qualify if:

• \>18 and \<45 years old.
• Able to understand the study requirements.
• Singleton pregnancy.
• Accept of written informed consent.

You may not qualify if:

• \<18 or \>45 years old.
• Not able to understand the study requirements.
• Multiple pregnancy.
• 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
• denial of written informed consent.

Sponsors & Collaborators

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

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

RECRUITING

Related Publications (2)

• Ullmo J, Cruz-Lemini M, Bos-Real L, Padilla M, Coma-Barbara M, Martorell S, Mora J, Ordonez-Llanos J, Llurba E; AngioCor working group. Cardiovascular risk assessment in women at high risk for pre-eclampsia in first half of pregnancy. Ultrasound Obstet Gynecol. 2025 Jul;66(1):65-72. doi: 10.1002/uog.29247. Epub 2025 Jun 5.

  PMID: 40471220 DERIVED

• 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.

  PMID: 34879854 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples, Placental samples, umbilical cord samples

MeSH Terms

Conditions

Pre-Eclampsia; Pregnancy Complications

Interventions

Hematologic Tests; Carotid Intima-Media Thickness

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Ultrasonography, Carotid Arteries; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques, Cardiovascular; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Elisa Llurba

  Institut de Recerca Hospital de la Santa Creu i Sant Pau

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisa Llurba

CONTACT

+0034932919000; ellurba@santpau.cat

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2019
• First Posted: November 14, 2019
• Study Start: February 1, 2020
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2023
• Last Updated: February 13, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)