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AzTrials

Cardiovascular BiomarkersPRECISENCT07463898

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

An observational study of Cardiovascular Biomarkers and Preeclampsia (PE) Risk, run by Washington University School of Medicine at 1 site in Nigeria.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 13 to 50 years, women onlyHealthy volunteers can take part
How many people
172 participants
Where
1 siteNigeria
Study dates
24 Apr 2026to Dec 2027
Phase
Observational
Are there results?
Not yet: the study is under way

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 13 to 50 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

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

Who may be able to join

  • • 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

Who cannot join

  • • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Zainab Mahmoud, MD, MSc contact

314-415-0009

zmahmoud@wustl.edu

Cecilia Nartey, MBChB, MPH contact

314-528-1082

c.nartey@wustl.edu

Nigeria1 site, 1 recruiting

  • University of Abuja Teaching Hospital

    Abuja

    Dike Ojji, MBBS, PhD, 234-806-009-4456, dike.ojji@uniabuja.edu.ng

    Dike Ojji, MBBS, PhD

    Recruiting

Other trials in Nigeria

About this study

Official title: 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?
Read more

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.
Read the 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.

Being tested
No Intervention: Observational Cohort
Keywords
cardiac phenotypes, preeclampsia, cardiovascular biomarkers
Medical subject headings
Pre-Eclampsia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No Intervention: Observational CohortOther

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

Study groups in NCT07463898
Study groupRoleWhat they receive
Single cohortSingle cohort of pregnant participants who are up to 20 weeks pregnant at enrollment
Receives: Other: No Intervention: Observational Cohort

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: At 12-16 weeks gestation and at 28-32 weeks gestation

Secondary outcomes (1)

  1. 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

    Measured: At 12-16 weeks and 28-32 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2026
  2. Study start24 Apr 2026
  3. Primary completionMay 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
172 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07463898
Sponsor's protocol ID
202601185
Acronym
PRECISE
Status last verified
Mar 2026
First submitted
5 Mar 2026
Last updated
27 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identifiied data will be made available to the research community following due process by way of data dictionaries, registries etc.

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

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiovascular Biomarkers and Preeclampsia (PE) Risk, run by Washington University School of Medicine at 1 site in Nigeria.

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 7 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: looking for participants now, as of the sponsor's last update on 27 Aug 2026. 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 Nigeria. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zainab Mahmoud, MD, MSc (314-415-0009, zmahmoud@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proteomic markers and cardiac-preE phenotypes (time frame: At 12-16 weeks gestation and at 28-32 weeks gestation). 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 NCT07463898, which also lists 1 linked publication.

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 27 Aug 2026.

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