[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590059":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":40,"responsibleParty":59,"collaborators":61,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":26,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":42,"whyStopped":26,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"University of Alabama at Birmingham","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"SBP PRS Dissemination","EXPERIMENTAL","Participants randomized to this arm will receive their personalized SBP polygenic risk score (PRS), along with structured genomic counseling sessions guided by the Health Belief Model and routine clinical care. Counseling will be delivered by trained genetic counselors at baseline and during 3-monthly in-person follow-up visits. The counseling is designed to increase perceived susceptibility, reduce perceived barriers, and improve self-efficacy for health behavior change.",[13],"Behavioral: SBP PRS Dissemination",{"label":15,"type":16,"description":17,"interventionNames":18},"Routine Clinical Care","ACTIVE_COMPARATOR","Participants randomized to this arm will receive standard clinical care for hypertension, including educational materials on blood pressure control, lifestyle modification, and cardiovascular health. These materials will be adapted from the American Heart Association Life's Essential 8 and the ACC preventive cardiology toolkit. Participants will not receive SBP PRS results or genomic counseling during the study. At the end-of-study visit (12 months), participants in this group will be offered their SBP PRS results and optional genomic counseling.",[19],"Behavioral: Regular Care",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Regular Care","Educational brochures and lifestyle guidance on blood pressure control, medication adherence, physical activity, and healthy diet, provided at baseline only. No additional counseling or genetic risk disclosure will occur during the 12-month intervention period.",[15],null,{"type":22,"name":9,"description":28,"armGroupLabels":29,"otherNames":26},"Participants receive individualized SBP PRS reports and structured genomic counseling sessions delivered by trained genetic counselors. Counseling addresses key constructs of the Health Belief Model, including perceived susceptibility, severity, and benefits of behavior change, with an emphasis on lifestyle modification and medication adherence.",[9],[31],{"name":32,"affiliation":5,"role":33},"Pankaj Arora, MD, FAHA","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":26,"email":39},"Nehal Vekariya, MS","CONTACT","2059347173","nvekariya@uabmc.edu",[41],{"facility":5,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"RECRUITING","Birmingham","Alabama","35294","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-86.80249,33.52066,{"lat":52,"lon":51},[55,57],{"name":36,"role":37,"phone":56,"phoneExt":26,"email":39},"205-934-7173",{"name":58,"role":33,"phone":26,"phoneExt":26,"email":26},"Pankaj Arora, MD",{"type":33,"investigatorFullName":58,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Associate Professor, Division of Cardiovasular Disease, Department of Medicine",[62],{"name":63,"class":64},"National Heart, Lung, and Blood Institute (NHLBI)","NIH","100590059","polygenic-risk-score-implementation-and-stratification-for-managing-blood-pressure-100590059",false,"NCT06962488","Polygenic Risk Score Implementation and Stratification for Managing Blood Pressure","Clinical Implementation of Blood Pressure Polygenic Risk Score","PRISM-BP","Inclusion Criteria:\n\n* Age 18 to 55 years (inclusive) at the time of screening.\n* Diagnosis of hypertension defined by 2017 ACC\u002FAHA guidelines, as evidenced by Resting office systolic blood pressure (SBP) of 130-160 mm Hg or Resting office diastolic blood pressure (DBP) of 80-100 mm Hg or Current use of antihypertensive medication.\n* Poor cardiovascular health, defined as Life's Essential 8 score \\\u003C50.\n* Willing and able to undergo 24-hour ambulatory blood pressure monitoring (ABPM) to confirm hypertension.\n* Able to provide informed consent.\n\nExclusion Criteria:\n\n* History of cardiovascular disease, including Myocardial infarction, Angina, Cardiac arrhythmia, Coronary heart disease, Heart failure, Stroke, or transient ischemic attack.\n* Body mass index (BMI) \\\u003C18.5 kg\u002Fm² or \\>45 kg\u002Fm².\n* Baseline office SBP \\>160 mm Hg or DBP \\>100 mm Hg.\n* Use of more than two antihypertensive medication classes.\n* Not hypertensive based on 24-hour ABPM (per 2017 ACC\u002FAHA criteria).\n* Pregnant or breastfeeding.\n* Estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin\u002F1.73 m² (using CKD-EPI equation).\n* Urine albumin-to-creatinine ratio ≥30 mg\u002Fg.\n* Hepatic transaminase levels \\>3× the upper limit of normal.\n* Significant psychiatric illness (assessed via Global Health Questionnaire-12).\n* Moderate or severe anxiety (Beck Anxiety Inventory \\[BAI\\] score \\>16).","ALL","18 Years","55 Years",{"count":77,"type":78},300,"ESTIMATED","INTERVENTIONAL",[81],"NA","In a multi-ethnic population, a genome-wide polygenic risk score (PRS) for systolic blood pressure (SBP), incorporating over one million common genetic variants, predicts blood pressure (BP) traits and the risk of adverse cardiovascular events beyond traditional risk factors. Delivering SBP PRS information to young and middle-aged adults with hypertension (HTN) and poor cardiovascular health (CVH) may enhance their motivation to adopt healthier lifestyles, improve blood pressure control, and ultimately reduce the risk of future cardiovascular disease (CVD). This randomized controlled trial will assess the impact of SBP PRS disclosure and theory-based genomic counseling on systolic blood pressure and health behaviors. A total of 300 adults aged 18-55 years will be enrolled and randomized to receive either routine clinical care or SBP PRS results with structured genomic counseling based on the Health Belief Model (HBM). Participants will be followed for 12 months. The primary outcome is change in 24-hour mean SBP from baseline to one year. Secondary outcomes include changes in physical activity, diet, medication adherence, smoking, lipid and glucose levels, and body composition. The study will also evaluate how behavior change is influenced by health beliefs, including perceived risk and self-efficacy. This study aims to advance the use of genomic tools in hypertension management and cardiovascular disease prevention.",[84,85],"Hypertension","Atherosclerotic Cardiovascular Disease",[87,88,89,90,91],"Systolic Blood Pressure","Polygenic Risk Score","Genomic Counseling","Health Belief Model","Cardiovascular Health","2025-09-02",{"date":94,"type":95},"2025-09-03","ACTUAL",{"date":97,"type":95},"2025-08-01",{"date":99,"type":78},"2030-07-31",{"name":5,"class":6},1]