[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658350":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":32,"studyPopulation":32,"armGroups":43,"interventions":61,"overallOfficials":80,"centralContacts":84,"locations":89,"responsibleParty":105,"collaborators":107,"id":111,"slug":112,"hasResults":113,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":119,"sex":120,"minAge":121,"maxAge":32,"enrollmentInfo":122,"targetDuration":32,"studyType":125,"phases":126,"briefSummary":128,"conditions":129,"keywords":32,"overallStatus":91,"whyStopped":32,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":143},{"fullName":5,"class":6},"Virginia Commonwealth University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":32,"otherOutcomes":32},[9,13,17,20,23,26,29],{"measure":10,"description":11,"timeFrame":12},"Change in cardiovagal baroreflex sensitivity","The change in cardiovagal baroreflex sensitivity will be assessed via the sequence method","Before and after 9 weeks of ADT or placebo",{"measure":14,"description":15,"timeFrame":16},"Change in blood pressure reactivity to the cold pressor test","The change in systolic blood pressure will be assessed from quiet rest to sympathetic activation using the cold pressor test","Before and after 9 weeks of androgen deprivation therapy or placebo",{"measure":18,"description":19,"timeFrame":16},"Change in exercise pressor reflex","The change in systolic blood pressure will be assessed from quiet rest to isometric handgrip exercise",{"measure":21,"description":22,"timeFrame":16},"Change in ambulatory blood pressure variability","Ambulatory systolic blood pressure variability will be determined from 24-hour ambulatory blood pressure monitoring using the standard deviation of blood pressure readings",{"measure":24,"description":25,"timeFrame":16},"Change in beat-to-beat blood pressure variability","Beat-to-beat systolic blood pressure variability will be determined using the standard deviation of blood pressure readings from finger photoplethysmography measured in the laboratory.",{"measure":27,"description":28,"timeFrame":16},"Change in renal vascular resistance","Renal blood flow will be determined using ultrasound and blood pressure will be determined using finger photoplethysmography. These measures will be used to estimate renal vascular resistance.",{"measure":30,"description":31,"timeFrame":16},"Change in kidney injury biomarkers","Neutrophil gelatinase-associated lipocalin (NGAL), tissue inhibitor of metalloproteinases 2 (TIMP2), and insulin-like growth factor binding protein 7 (IGFBP7) will be quantified in urine using commercially available assay kits. Concentrations will be normalized to urinary flow rate.",null,{"allocation":34,"interventionModel":35,"interventionModelDescription":32,"primaryPurpose":36,"observationalModel":32,"timePerspective":32,"maskingInfo":37},"RANDOMIZED","PARALLEL","BASIC_SCIENCE",{"masking":38,"maskingDescription":32,"whoMasked":39},"TRIPLE",[40,41,42],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR",[44,51,55],{"label":45,"type":46,"description":47,"interventionNames":48},"Prostate Cancer","ACTIVE_COMPARATOR","Men undergoing androgen deprivation therapy via gonadotropin releasing hormone agonist plus androgen receptor inhibitor for the treatment of prostate cancer",[49,50],"Drug: Gonadotropin Releasing Hormone Agonists (GNRH)","Drug: Androgen receptor (AR) inhibitor",{"label":52,"type":46,"description":53,"interventionNames":54},"Healthy + ADT","Healthy men undergoing gonadal suppression via gonadotropin releasing hormone agonist plus androgen receptor inhibitor for 9 weeks",[49,50],{"label":56,"type":57,"description":58,"interventionNames":59},"Healthy + Placebo","PLACEBO_COMPARATOR","Healthy men undergoing placebo for 9 weeks.",[60],"Drug: Placebo",[62,69,76],{"type":63,"name":64,"description":65,"armGroupLabels":66,"otherNames":67},"DRUG","Gonadotropin Releasing Hormone Agonists (GNRH)","8 weeks of GnRH agonist",[52,45],[68],"Leuprolide",{"type":63,"name":70,"description":71,"armGroupLabels":72,"otherNames":73},"Androgen receptor (AR) inhibitor","2 weeks of AR inhibitor",[52,45],[74,75],"Bicalutamide","Flutamide",{"type":63,"name":77,"description":78,"armGroupLabels":79,"otherNames":32},"Placebo","Placebo tablet and injection",[56],[81],{"name":82,"affiliation":5,"role":83},"Matthew Babcock, PhD","PRINCIPAL_INVESTIGATOR",[85],{"name":82,"role":86,"phone":87,"phoneExt":32,"email":88},"CONTACT","‪(804) 396-4718‬","babcockmc@vcu.edu",[90],{"facility":5,"status":91,"city":92,"state":93,"zip":94,"country":95,"countryCode":96,"cosmosGeoPoint":97,"geoPoint":102,"contacts":103},"RECRUITING","Richmond","Virginia","23220","United States","US",{"type":98,"coordinates":99},"Point",[100,101],-77.46026,37.55376,{"lat":101,"lon":100},[104],{"name":82,"role":86,"phone":87,"phoneExt":32,"email":88},{"type":106,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[108],{"name":109,"class":110},"National Heart, Lung, and Blood Institute (NHLBI)","NIH","100658350","phase-4-autonomic-and-renal-contributions-to-hypertension-with-adt-100658350",false,"NCT07848828","Autonomic and Renal Contributions to Hypertension With ADT","Autonomic and Renal Contributions to Hypertension With Androgen Deprivation Therapy","ARCH","Inclusion Criteria:\n\n* age 40+ years;\n* resting blood pressure \\\u003C140\u002F90 mmHg;\n* fasted blood glucose \\\u003C126 mg\u002FdL;\n* testosterone ≥400 ng\u002FdL;\n* sedentary to recreationally active;\n* nonsmokers;\n* healthy as determined by medical history, physical exam, blood and urine chemistries and resting and exercise ECG during a physician supervised graded exercise treadmill test OR recent diagnosis of non-metastatic prostate cancer with plans to undergo androgen deprivation therapy;\n* PSA \\\u003C4.00 ng\u002FdL if in the non-cancer group;\n* Gleason Score ≤7 if in the prostate cancer group;\n* no use of medications that might influence cardiovascular function (e.g., antihypertensives, lipid-lowering medications);\n* willing and able to be on GnRHagonist and AR inhibitor;\n* not taking antioxidant vitamins, corticosteroids, or anti-inflammatory medications, or willing to stop use for four weeks prior to the start of the study;\n* not using exogenous sex hormones for at least one year\n\nExclusion Criteria:\n\n* -acute liver disease;\n* chronic kidney disease, serum creatinine \\>1.3 mg\u002FdL, macroalbuminuria \\>300 mg\u002Fg of proteinuria\n* pre-existing or active cardiac, renal or hepatic disease, epilepsy or other seizure disorder;\n* diabetes, active or chronic infection, disease that affects the nervous system;\n* Gleason Score ≥8;\n* thyroid dysfunction, defined as ultrasensitive TSH \\\u003C0.5 or \\>5.0 mU\u002FL, volunteers with abnormal TSH values will be re-considered for participation after follow-up evaluation by the PCP with initiation or adjustment of thyroid hormone replacement;\n* tobacco use within the previous 12 months",true,"MALE","40 Years",{"count":123,"type":124},50,"ESTIMATED","INTERVENTIONAL",[127],"PHASE4","This study plans to learn more about contributors to high blood pressure in men who undergo androgen deprivation therapy (ADT) to treat prostate cancer. Prostate cancer is the most common non-skin cancer in men, affecting approximately 1 in 8 American men and its primary treatment is through the use of ADT. However, ADT increases the likelihood of developing heart disease including high blood pressure. This study will determine if dysfunction of the nervous system and\u002For kidneys occurs in men undergoing ADT, as these systems play a significant role in control of blood pressure. The results from this study will help us understand the ways in which ADT contributes to heart disease and help us develop therapies to prevent heart disease in prostate cancer survivors.",[130,45,131,132,133],"Androgen Deprivation Therapy","Hypertension","Autonomic Dysfunction","Renal Disease","2026-09-23",{"date":136,"type":137},"2026-09-30","ACTUAL",{"date":139,"type":137},"2026-08-01",{"date":141,"type":124},"2030-07",{"name":5,"class":6},1]