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NCT Number: NCT07463898

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.

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.

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Key information

Age range

13 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

University of Abuja Teaching Hospital

Abuja, Nigeria

Location contact

Dike Ojji, MBBS, PhD

CONTACT

[email protected]

234-806-009-4456

Dike Ojji, MBBS, PhD

PRINCIPAL_INVESTIGATOR

About this study

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

  • 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).
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No Intervention: Observational Cohort

Other

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

Primary outcomes

  1. Proteomic markers and cardiac-preE phenotypes

    Time frame: At 12-16 weeks gestation and at 28-32 weeks gestation

    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).

Secondary outcomes

  1. Proteomic markers and hypertensive disorders of pregnancy versus normal pregnancy

    Time frame: At 12-16 weeks and 28-32 weeks

    Differences in cardiovascular proteomic patterns (pregnancy weeks 12-16 and 28-32 by pregnancy outcome: PreE/ peripartum HF vs. normal pregnancy

Study contacts

Contact information is provided by the study sponsor or research team.

Cecilia Nartey, MBChB, MPH

CONTACT

[email protected]

314-528-1082

Zainab Mahmoud, MD, MSc

CONTACT

[email protected]

314-415-0009

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • University of Abuja Teaching Hospital
  • Vanderbilt University Medical Center

Registry information

Official study title

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

Acronym: PRECISE

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 11, 2026
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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