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| Name | Class |
|---|---|
| Vanderbilt University Medical Center | OTHER |
| University of Abuja Teaching Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single cohort | Single cohort of pregnant participants who are up to 20 weeks pregnant at enrollment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention: Observational Cohort | Other | This is an observational study, and there is no intervention. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | At 12-16 weeks gestation and at 28-32 weeks gestation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At 12-16 weeks and 28-32 weeks |
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Inclusion Criteria:
• Pregnant women who are up to 20 weeks pregnant
Exclusion Criteria:
• Known cardiac disease (e.g., cardiomyopathy, coronary artery disease [CAD])
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Participants will be enrolled from primary health centers, and who are co-enrolled in the ENHANCE-CVH trial.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zainab Mahmoud, MD, MSc | Contact | 314-415-0009 | zmahmoud@wustl.edu | |
| Cecilia Nartey, MBChB, MPH | Contact | 314-528-1082 | c.nartey@wustl.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Abuja Teaching Hospital | Abuja | Nigeria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 1. Trends in maternal mortality 2000 to 2020: estimates by WHO, UNICEF, UNFPA, World Bank Group and UNDESA/Population Division. Accessed March 8, 2023. https://www.who.int/publications/i/item/9789240068759 2. Williams D, Stout MJ, Rosenbloom JI, et al. Preeclampsia Predicts Risk of Hospitalization for Heart Failure With Preserved Ejection Fraction. J Am Coll Cardiol. 2021;78(23):2281-2290. doi:10.1016/j.jacc.2021.09.1360 3. Honigberg MC, Zekavat SM, Aragam K, et al. Long-Term Cardiovascular Risk in Women With Hypertension During Pregnancy. J Am Coll Cardiol. 2019;74(22):2743-2754. doi:10.1016/j.jacc.2019.09.052 4. Adil M, Kolarova TR, Doebley AL, et al. Preeclampsia risk prediction from prenatal cell-free DNA screening. Nat Med. Published online 2025:1-7. doi:10.1038/s41591-025-03509-w 5. Zawiejska A, Wender-Ozegowska E, Iciek R, Brazert J. Concentrations of endothelial nitric oxide synthase, angiotensin-converting enzyme, vascular endothelial growth factor and placental growth factor in maternal blood and maternal metabolic status in pregnancy complicated by hypertensive disorders. J Hum Hypertens. 2014;28(11):670-676. doi:10.1038/jhh.2014.42 6. Bian Z, Shixia C, Duan T. First-Trimester Maternal Serum Levels of sFLT1, PGF and ADMA Predict Preeclampsia. PLoS ONE. 2015;10(4):e0124684. doi:10.1371/journal.pone.0124684 7. Lindley KJ, Perry A, Jacobs M, et al. Differences in Cardiometabolic Proteins in Pregnancy Prioritize Relevant Targets of Preeclampsia. Arter, Thromb, Vasc Biol. 2024;44(4):969-975. doi:10.1161/atvbaha.124.320737 |
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De-identifiied data will be made available to the research community following due process by way of data dictionaries, registries etc.
For a prespecified duration indicated via formal request
Only authorized persons who have gone through due process in securing permission will be given access to data dictionaries
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Blood samples drawn or taken from participants will be retained.
| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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