PreeclampsiaANGIOCORNCT04162236
Cardiac Dysfunction and Remodeling in Patients With Preeclampsia
An observational study of Preeclampsia and Cardiovascular Risk Factor, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia, Cardiovascular Risk Factor, Pregnancy Complications
- What is being tested?
- Ecocardiographyc ultrasound
- How many people
- 440 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2020to 1 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women at high risk of <preeclampsia on first trimestre scan
Who may be able to join
- >18 and <45 years old.
- Able to understand the study requirements.
- Singleton pregnancy.
- Accept of written informed consent.
Who cannot join
- <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
- known major fetal anomaly or chromosomal abnormality at inclusion
- denial of written informed consent.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Elisa Llurba, MD, PhD, +34935537041, ellurba@santpau.cat
About this study
Official title: Cardiac Dysfunction and Remodeling in Patients With Preeclampsia Regulated by Antiangiogenic Environment: Clinical and Experimental Approach
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.
Read the 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.
- Being tested
- Ecocardiographyc ultrasound
- Medical subject headings
- Pre-Eclampsia, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ecocardiographyc ultrasoundDiagnostic test
Also called Blood test, Carotid intima thickness
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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). Receives: 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). Receives: Diagnostic Test: Ecocardiographyc ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Venous blood will be drawn, with informed consent, from the cubital vein without a tourniquet and using a 20-G needle into Vacutainer CPT
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study start1 Feb 2020
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisa Llurba, Principal investigator, Institut de Recerca Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04162236
- Sponsor's protocol ID
- IIBSP-PRE-2019-63
- Acronym
- ANGIOCOR
- Status last verified
- Feb 2020
- First submitted
- 11 Nov 2019
- Last updated
- 13 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40471220Ullmo 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.
PubMed 34879854
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Dysfunction and Remodeling in Patients With Preeclampsia Regulated by Antiangiogenic Environment: Clinical and Experimental Approach
- ClinicalTrials.gov ID
- NCT04162236
- Acronym / sponsor ID
- ANGIOCOR / IIBSP-PRE-2019-63
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 14 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High Risk of Preeclampsia | – | Diagnostic Test: Ecocardiographyc ultrasoundWomen 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) |
| Patients with Preeclampsia | – | Diagnostic Test: Ecocardiographyc ultrasoundWomen 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). |
| Control group | – | Diagnostic Test: Ecocardiographyc ultrasoundHealthy pregnant women with at low risk PE screening at 11.0 to 13.6 weeks of gestation (n=100). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women at high risk of <preeclampsia on first trimestre scan
Key inclusion criteria (4 listed)
- >18 and <45 years old.
- Able to understand the study requirements.
- Singleton pregnancy.
- Accept of written informed consent.
Key exclusion criteria (6 listed)
- <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
- known major fetal anomaly or chromosomal abnormality at inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ecocardiographyc ultrasoundAlso: Blood test, Carotid intima thickness* 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. | Diagnostic test | Control group, High Risk of Preeclampsia, Patients with Preeclampsia |
Primary outcome
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.
Time frame: 12 months
- 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)
1 secondary outcome
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
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2020.
- Derived from this study: PubMed 40471220Ullmo 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.
- Derived from this study: PubMed 34879854Ullmo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisa Llurba principal investigator
Institut de Recerca Hospital de la Santa Creu i Sant Pau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preeclampsia and Cardiovascular Risk Factor, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elisa Llurba (+0034932919000, ellurba@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04162236, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2020.