Cardiac Dysfunction and Remodeling in Patients With Preeclampsia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

440 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-01

Study Completion Date

2023-01-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Preeclampsia Cardiovascular Risk Factor Pregnancy Complications

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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)

Ecocardiographyc ultrasound

Intervention Type 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.

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).

Ecocardiographyc ultrasound

Intervention Type 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.

Control group

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

Ecocardiographyc ultrasound

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Blood test Carotid intima thickness

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes