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.

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Proteomic markers and cardiac-preE phenotypes [Срок оценки: At 12-16 weeks gestation and at 28-32 weeks gestation]

Вторичные конечные точки (1)

• Proteomic markers and hypertensive disorders of pregnancy versus normal pregnancy [Срок оценки: At 12-16 weeks and 28-32 weeks]

Критерии участия

Критерии включения

• • 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

Критерии исключения

• • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Nigeria · 1 центр

• University of Abuja Teaching Hospital — Abuja

Публикации

• 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.

Идентификаторы

NCT: NCT07463898 · 202601185

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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