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.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No Intervention: Observational Cohort.
- Who it may be relevant to
- Registry conditions: Cardiovascular Biomarkers, Preeclampsia (PE) Risk, Preeclampsia (PE). Basic parameters: 13 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Nigeria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
PRoteomics and EchoCardiography for Identifying Subclinical Cardiac Dysfunction in Preeclampsia (PRECISE)
Overview
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.
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.
Interventions
- Other No Intervention: Observational Cohort
This is an observational study, and there is no intervention.
Primary outcome measures
- Proteomic markers and cardiac-preE phenotypes [Time frame: At 12-16 weeks gestation and at 28-32 weeks gestation]
Secondary outcome measures (1)
- Proteomic markers and hypertensive disorders of pregnancy versus normal pregnancy [Time frame: At 12-16 weeks and 28-32 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Nigeria · 1 center
- University of Abuja Teaching Hospital — Abuja
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.
Identifiers
NCT: NCT07463898 · 202601185