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.

NCT07463898 | Not Yet Recruiting

• 1 other identifier: 202601185
• Study Type: observational
• Target: 172
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiovascular Biomarkers; Preeclampsia (PE) Risk; Preeclampsia (PE)

Keywords

cardiac phenotypes; preeclampsia; cardiovascular biomarkers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Proteomic markers and hypertensive disorders of pregnancy versus normal pregnancy

  At 12-16 weeks and 28-32 weeks

Study Arms (1)

Single cohort

Single cohort of pregnant participants who are up to 20 weeks pregnant at enrollment

Other: No Intervention: Observational Cohort

Interventions

No Intervention: Observational Cohort OTHER

This is an observational study, and there is no intervention.

Single cohort

Eligibility Criteria

• Age: 13 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Vanderbilt University Medical Center: collaborator
• University of Abuja Teaching Hospital: collaborator

Study Sites (1)

University of Abuja Teaching Hospital

Abuja, Nigeria

Location

Related Publications (1)

• 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

  BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples drawn or taken from participants will be retained.

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Zainab Mahmoud, MD, MSc

CONTACT

314-415-0009; zmahmoud@wustl.edu

Cecilia Nartey, MBChB, MPH

CONTACT

314-528-1082; c.nartey@wustl.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: March 11, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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

Locations

NG (1)