A Study to Find and Confirm Blood-based Markers (Called Proteins) That May Show Early Heart Changes in Women With Preeclampsia, Even Before Symptoms Appear, and the Use of Heart Ultrasound (Echocardiography) to Look at Patterns of How the Heart Changes During Pregnancy in Women With Preeclampsia. (PRECISE)

PRoteomics and EchoCardiography for Identifying Subclinical Cardiac Dysfunction in Preeclampsia (PRECISE)

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:

• Do these blood markers relate to heart changes on ultrasound?
• How may they help predict future health problems for the mother?

Participants will:

• Complete a 20-minute survey that will include taking your baseline demographic information, clinical information/medical history, asking about pre-existing health conditions, including measuring your height, weight, and blood pressure.
• Have transthoracic echocardiography (TTE) performed at 12 - 16 weeks gestation and again at 28 - 32 weeks gestation.
• Provide a blood sample for these protein measurements. These samples will be collected at intake (12 - 16 weeks gestation) and again at 28 - 32 weeks gestation.

Study Overview

• Status: Not yet recruiting
• Conditions: Preeclampsia (PE); Cardiovascular Biomarkers; Preeclampsia (PE) Risk
• Intervention / Treatment: Other: No Intervention: Observational Cohort

Detailed Description

This is a prospective cohort study designed to recruit about 172 participants with the following aims:

1. To assess the relationship between cardiovascular proteomic patterns and echocardiographic Cardiac-PreE phenotypes. Hypothesis: Proteomic signatures (between 12-16 and 28-32 weeks) will correlate with echocardiographic changes (LVMI, LVDD, LVSD).
2. To identify differential proteomic profiles by pregnancy outcome (PreE/peripartum HF vs. normal pregnancy). Hypothesis: Changes in protein expression correlate with pregnancy outcomes and Cardiac-PreE phenotype severity.

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.

• Study Type: Observational
• Enrollment (Estimated): 172

Contacts and Locations

• Study Contact: Name: Zainab Mahmoud, MD, MSc; Phone Number: 314-415-0009; Email: zmahmoud@wustl.edu
• Study Contact Backup: Name: Cecilia Nartey, MBChB, MPH; Phone Number: 314-528-1082; Email: c.nartey@wustl.edu

Study Locations

• Nigeria
  • Abuja, Nigeria
    • University of Abuja Teaching Hospital
    • Contact: Dike Ojji, MBBS, PhD; Phone Number: 234-806-009-4456; Email: dike.ojji@uniabuja.edu.ng
    • Principal Investigator: Dike Ojji, MBBS, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Participants will be enrolled from primary health centers, and who are co-enrolled in the ENHANCE-CVH trial.

Description

Inclusion Criteria:

• • Pregnant women who are up to 20 weeks pregnant

  • Able to consent to participate in the study
  • Are enrolled in the ENHANCE-CVH study
  • Willing to undergo echocardiography and blood draws

Exclusion Criteria:

• • Known cardiac disease (e.g., cardiomyopathy, coronary artery disease [CAD])

  • Sickle cell disease
  • Pulmonary arterial hypertension
  • Pulmonary embolism
  • Inability to provide informed consent
  • Acute Illness
  • Malignancy

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Single cohort; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: Vanderbilt University Medical Center; University of Abuja Teaching Hospital

Publications and helpful links

General Publications

• 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

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: March 5, 2026
• First Submitted That Met QC Criteria: March 5, 2026
• First Posted (Actual): March 11, 2026

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 5, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: preeclampsia; cardiovascular biomarkers; cardiac phenotypes
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Hypertension, Pregnancy-Induced; Pre-Eclampsia
• Other Study ID Numbers: 202601185

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identifiied data will be made available to the research community following due process by way of data dictionaries, registries etc.
• IPD Sharing Time Frame: For a prespecified duration indicated via formal request
• IPD Sharing Access Criteria: Only authorized persons who have gone through due process in securing permission will be given access to data dictionaries
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No