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

ConditionsCardiovascular Biomarkers Preeclampsia (PE) Risk Preeclampsia (PE)

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexFemale

Age13-50

SponsorWashington University School of Medicine

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

• 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

Disqualifiers

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

Sickle cell disease

Pulmonary arterial hypertension

Pulmonary embolism

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

No Intervention: Observational Cohort
Other intervention
This is an observational study, and there is no intervention.

Treatment groups

172 Participants

are divided into 1 treatment group

Group A: Single cohort1 intervention

Trial outcomes

Primary outcomes

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).

Time frame

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

Secondary outcomes

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

Time frame

At 12-16 weeks and 28-32 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Washington University School of Medicine

Lead sponsor

Vanderbilt University Medical Center

Collaborator

University of Abuja Teaching Hospital