[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628612":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":22,"studyPopulation":23,"armGroups":24,"interventions":30,"overallOfficials":18,"centralContacts":35,"locations":45,"responsibleParty":65,"collaborators":68,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":80,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":18,"studyType":87,"phases":18,"briefSummary":88,"conditions":89,"keywords":93,"overallStatus":48,"whyStopped":18,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Washington University School of Medicine","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"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).","At 12-16 weeks gestation and at 28-32 weeks gestation",[14],{"measure":15,"description":16,"timeFrame":17},"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\u002F peripartum HF vs. normal pregnancy","At 12-16 weeks and 28-32 weeks",null,{"allocation":18,"interventionModel":18,"interventionModelDescription":18,"primaryPurpose":18,"observationalModel":20,"timePerspective":21,"maskingInfo":18},"COHORT","PROSPECTIVE","This is a prospective cohort study designed to recruit about 172 participants with the following aims:\n\n1. 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).\n2. To identify differential proteomic profiles by pregnancy outcome (PreE\u002Fperipartum HF vs. normal pregnancy). Hypothesis: Changes in protein expression correlate with pregnancy outcomes and Cardiac-PreE phenotype severity.\n\nTransthoracic 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:\n\nAt 12-16 weeks and 28-32 weeks:\n\nClinical assessment\u002FIntake 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.\n\nParticipants will be recruited from 10 of the active ENHANCE-CVH trial participating sites\u002F 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.\n\nAll TTEs will be conducted at the cardiology unit at UATH by trained cardiologists.","Participants will be enrolled from primary health centers, and who are co-enrolled in the ENHANCE-CVH trial.",[25],{"label":26,"type":18,"description":27,"interventionNames":28},"Single cohort","Single cohort of pregnant participants who are up to 20 weeks pregnant at enrollment",[29],"Other: No Intervention: Observational Cohort",[31],{"type":6,"name":32,"description":33,"armGroupLabels":34,"otherNames":18},"No Intervention: Observational Cohort","This is an observational study, and there is no intervention.",[26],[36,41],{"name":37,"role":38,"phone":39,"phoneExt":18,"email":40},"Zainab Mahmoud, MD, MSc","CONTACT","314-415-0009","zmahmoud@wustl.edu",{"name":42,"role":38,"phone":43,"phoneExt":18,"email":44},"Cecilia Nartey, MBChB, MPH","314-528-1082","c.nartey@wustl.edu",[46],{"facility":47,"status":48,"city":49,"state":18,"zip":18,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"University of Abuja Teaching Hospital","RECRUITING","Abuja","Nigeria","NG",{"type":53,"coordinates":54},"Point",[55,56],7.49508,9.05785,{"lat":56,"lon":55},[59,63],{"name":60,"role":38,"phone":61,"phoneExt":18,"email":62},"Dike Ojji, MBBS, PhD","234-806-009-4456","dike.ojji@uniabuja.edu.ng",{"name":60,"role":64,"phone":18,"phoneExt":18,"email":18},"PRINCIPAL_INVESTIGATOR",{"type":64,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Zainab Mahmoud","Assistant Professor of Medicine",[69,71],{"name":70,"class":6},"Vanderbilt University Medical Center",{"name":47,"class":6},"100628612","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-100628612",false,"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","PRoteomics and EchoCardiography for Identifying Subclinical Cardiac Dysfunction in Preeclampsia (PRECISE)","PRECISE","Inclusion Criteria:\n\n* • Pregnant women who are up to 20 weeks pregnant\n\n  * Able to consent to participate in the study\n  * Are enrolled in the ENHANCE-CVH study\n  * Willing to undergo echocardiography and blood draws\n\nExclusion Criteria:\n\n* • Known cardiac disease (e.g., cardiomyopathy, coronary artery disease \\[CAD\\])\n\n  * Sickle cell disease\n  * Pulmonary arterial hypertension\n  * Pulmonary embolism\n  * Inability to provide informed consent\n  * Acute Illness\n  * Malignancy",true,"FEMALE","13 Years","50 Years",{"count":85,"type":86},172,"ESTIMATED","OBSERVATIONAL","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:\n\n* Do these blood markers relate to heart changes on ultrasound?\n* How may they help predict future health problems for the mother?\n\nParticipants will:\n\n* Complete a 20-minute survey that will include taking your baseline demographic information, clinical information\u002Fmedical history, asking about pre-existing health conditions, including measuring your height, weight, and blood pressure.\n* Have transthoracic echocardiography (TTE) performed at 12 - 16 weeks gestation and again at 28 - 32 weeks gestation.\n* 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.",[90,91,92],"Cardiovascular Biomarkers","Preeclampsia (PE) Risk","Preeclampsia (PE)",[94,95,96],"cardiac phenotypes","preeclampsia","cardiovascular biomarkers","2026-08-24",{"date":99,"type":100},"2026-08-27","ACTUAL",{"date":102,"type":100},"2026-04-24",{"date":104,"type":86},"2027-12",{"name":5,"class":6},1]