University of Abuja Teaching Hospital
Abuja, Nigeria
Location contact
Dike Ojji, MBBS, PhD
CONTACT
Dike Ojji, MBBS, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07463898
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.
Trial opening soon.
Get Notified13 year–50 year
Female
Observational
Abuja, Nigeria
Dike Ojji, MBBS, PhD
CONTACT
Dike Ojji, MBBS, PhD
PRINCIPAL_INVESTIGATOR
This is a prospective cohort study designed to recruit about 172 participants with the following aims:
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This is an observational study, and there is no intervention.
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).
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
Contact information is provided by the study sponsor or research team.
Cecilia Nartey, MBChB, MPH
CONTACT
Zainab Mahmoud, MD, MSc
CONTACT
Washington University School of Medicine
Other
PRoteomics and EchoCardiography for Identifying Subclinical Cardiac Dysfunction in Preeclampsia (PRECISE)
Acronym: PRECISE
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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