An observational study in Cardiovascular Biomarkers, Preeclampsia (PE) Risk and Preeclampsia (PE), sponsored by Washington University School of Medicine. Recruiting at 1 site in Nigeria. Open to female participants aged 13 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by Washington University School of Medicine · Observational
The goal of this study is to find and confirm blood-based markers (called proteins) that may show early heart changes in women with preeclampsia, even before symptoms appear. It will also use heart ultrasound (echocardiography) to look at patterns of how the heart changes during pregnancy in women with preeclampsia. The main questions it aims to answer are:
Participants will:
This is a prospective cohort study designed to recruit about 172 participants with the following aims:
Transthoracic echocardiography (TTE) will be performed at 12-16 and 28-32 weeks, and blood will be collected at both weeks 12-16 and 28-32, centrifuged to generate cell-free plasma and frozen at -80°C until use. We will analyze for 5,400 proteins using OLINK explore to identify proteins linked to Cardiac-PreE phenotypes. Echocardiographic investigations will be performed by trained cardiology specialists to assess LV mass index (LVMI), LV ejection fraction (LVEF) and diastolic function. The breakdown of procedures following enrollment are as follows:
At 12-16 weeks and 28-32 weeks:
Clinical assessment/Intake survey Transthoracic echocardiography (TTE) Venous blood samples (centrifuged and stored at -80°C) Participants will be co-enrolled from ENHANCE-CVH trial. Baseline demographic data from ENHANCE-CVH will be used to avoid duplication and minimize participant burden. ENHANCE-CVH trial study procedures do not include either transthoracic echocardiography or blood sample withdrawal for assessing biomarkers. Thus, there will be no duplication of procedures or overlapping endpoints.
Participants will be recruited from 10 of the active ENHANCE-CVH trial participating sites/ PHCs in the federal capital territory, Abuja, Nigeria. Consenting participants will have a separate clinic visit at UATH for PRECISE study procedures and will receive separate transportation allowance for this purpose.
All TTEs will be conducted at the cardiology unit at UATH by trained cardiologists.
916 studies on the registry are indexed under Pre-Eclampsia; 243 are open to participants now.
This study's planned enrollment of 172 is close to the median of 165 across 397 observational studies indexed under Pre-Eclampsia.
Browse Pre-Eclampsia studies →Washington University School of Medicine is the lead sponsor of 1,803 studies on the registry; 271 are open to participants now.
Of its 329 completed or terminated interventional studies of FDA-regulated products, 216 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants will be enrolled from primary health centers, and who are co-enrolled in the ENHANCE-CVH trial.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Pregnant women who are up to 20 weeks pregnant
Exclusion Criteria:
Known cardiac disease (e.g., cardiomyopathy, coronary artery disease [CAD])
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single cohort of pregnant participants who are up to 20 weeks pregnant at enrollment
Other: No Intervention: Observational Cohort
This is an observational study, and there is no intervention.
Proteomic markers and cardiac-preE phenotypes
Correlation between change in serum proteomic signatures (change from 12 - 16 weeks and 28 - 32 weeks) and change in echocardiographic Cardiac-PreE phenotypes (ie, LVMI, LVDD, LVSD) (change from 12 - 16 weeks and 28 - 32 weeks).
Time frame: At 12-16 weeks gestation and at 28-32 weeks gestation
Proteomic markers and hypertensive disorders of pregnancy versus normal pregnancy
Differences in cardiovascular proteomic patterns (pregnancy weeks 12-16 and 28-32 by pregnancy outcome: PreE/ peripartum HF vs. normal pregnancy
Time frame: At 12-16 weeks and 28-32 weeks
Plan to share: Yes — De-identifiied data will be made available to the research community following due process by way of data dictionaries, registries etc.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: For a prespecified duration indicated via formal request
Access criteria: Only authorized persons who have gone through due process in securing permission will be given access to data dictionaries
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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