[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100495506":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":36,"locations":42,"responsibleParty":213,"collaborators":25,"id":216,"slug":217,"hasResults":218,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":222,"eligibilityCriteria":223,"healthyVolunteers":218,"sex":224,"minAge":225,"maxAge":25,"enrollmentInfo":226,"targetDuration":25,"studyType":229,"phases":230,"briefSummary":232,"conditions":233,"keywords":25,"overallStatus":45,"whyStopped":25,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":245},{"fullName":5,"class":6},"Peking University First Hospital","OTHER",[8,15],{"label":9,"type":6,"description":10,"interventionNames":11},"Not stenting","Hyperemic FFR induced by 50μg\u002Fkg of dopamine via renal artery will be measured. If FFR is ≥0.80, randomization will be applied, and no stenting will be implanted. If FFR is \\\u003C0.80, randomization will be ignored, and stenting will be performed.",[12,13,14],"Drug: Dopamine","Diagnostic Test: Fractional Flow Reserve, Renal","Device: Renal artery stenting",{"label":16,"type":6,"description":17,"interventionNames":18},"Stenting","Hyperemic FFR induced by 50μg\u002Fkg of dopamine via renal artery will be measured. No matter FFR is, stenting will be performed as planned.",[12,13,14],[20,26,31],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Dopamine","A bolus dose of 50μg\u002Fkg dopamine via renal artery to induce hyperemic status",[9,16],null,{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":25},"DIAGNOSTIC_TEST","Fractional Flow Reserve, Renal","Renal FFR will be measured based on SOP",[9,16],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":25},"DEVICE","Renal artery stenting","Renal artery stenting will be implanted based on the protocol",[9,16],[37],{"name":38,"role":39,"phone":40,"phoneExt":25,"email":41},"Yuxi Li, MD","CONTACT","00861083572283","liyuxi@pku.edu.cn",[43,63,74,85,95,105,119,133,147,161,174,189,203],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"China-Japan Friendship Hospital","RECRUITING","Beijing","Beijing Municipality","100029","China","CN",{"type":52,"coordinates":53},"Point",[54,55],116.39723,39.9075,{"lat":55,"lon":54},[58,60],{"name":59,"role":39,"phone":25,"phoneExt":25,"email":25},"Wuqiang Che, MD",{"name":61,"role":62,"phone":25,"phoneExt":25,"email":25},"Jingang Zheng, MD","PRINCIPAL_INVESTIGATOR",{"facility":5,"status":45,"city":46,"state":47,"zip":64,"country":49,"countryCode":50,"cosmosGeoPoint":65,"geoPoint":67,"contacts":68},"100034",{"type":52,"coordinates":66},[54,55],{"lat":55,"lon":54},[69,70,72],{"name":38,"role":39,"phone":40,"phoneExt":25,"email":41},{"name":71,"role":62,"phone":25,"phoneExt":25,"email":25},"Jianping Li, MD",{"name":38,"role":73,"phone":25,"phoneExt":25,"email":25},"SUB_INVESTIGATOR",{"facility":75,"status":45,"city":46,"state":47,"zip":76,"country":49,"countryCode":50,"cosmosGeoPoint":77,"geoPoint":79,"contacts":80},"Beijing Chao-yang hospital, capital medical university","100123",{"type":52,"coordinates":78},[54,55],{"lat":55,"lon":54},[81,83],{"name":82,"role":39,"phone":25,"phoneExt":25,"email":25},"Chuang Li, MD",{"name":84,"role":62,"phone":25,"phoneExt":25,"email":25},"Li Xu, MD",{"facility":86,"status":45,"city":46,"state":47,"zip":25,"country":49,"countryCode":50,"cosmosGeoPoint":87,"geoPoint":89,"contacts":90},"Beijing Anzhen Hospital, Capital Medical University",{"type":52,"coordinates":88},[54,55],{"lat":55,"lon":54},[91,93],{"name":92,"role":39,"phone":25,"phoneExt":25,"email":25},"Miao Yu, MD",{"name":94,"role":62,"phone":25,"phoneExt":25,"email":25},"Dongmei Shi, MD",{"facility":96,"status":45,"city":46,"state":47,"zip":25,"country":49,"countryCode":50,"cosmosGeoPoint":97,"geoPoint":99,"contacts":100},"Beijing Friendship Hospital, Capital Medical University",{"type":52,"coordinates":98},[54,55],{"lat":55,"lon":54},[101,103],{"name":102,"role":39,"phone":25,"phoneExt":25,"email":25},"Jixuan Liu, MD",{"name":104,"role":62,"phone":25,"phoneExt":25,"email":25},"Hui Chen, MD",{"facility":106,"status":45,"city":107,"state":108,"zip":25,"country":49,"countryCode":50,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"The Second Affiliated Hospital of Chongqing Medical University","Chongqing","Chongqing Municipality",{"type":52,"coordinates":110},[111,112],106.55771,29.56026,{"lat":112,"lon":111},[115,117],{"name":116,"role":39,"phone":25,"phoneExt":25,"email":25},"Guozhu Chen, MD",{"name":118,"role":62,"phone":25,"phoneExt":25,"email":25},"Li Su, MD",{"facility":120,"status":45,"city":121,"state":122,"zip":25,"country":49,"countryCode":50,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"The Second Affiliated Hospital of Soochow University","Suzhou","Jiangsu",{"type":52,"coordinates":124},[125,126],120.59538,31.30408,{"lat":126,"lon":125},[129,131],{"name":130,"role":39,"phone":25,"phoneExt":25,"email":25},"Li Xiang, MD",{"name":132,"role":62,"phone":25,"phoneExt":25,"email":25},"Hui Li, MD",{"facility":134,"status":45,"city":135,"state":136,"zip":25,"country":49,"countryCode":50,"cosmosGeoPoint":137,"geoPoint":141,"contacts":142},"The Second Affiliated Hospital of Nanchang University","Nanchang","Jiangxi",{"type":52,"coordinates":138},[139,140],115.85306,28.68396,{"lat":140,"lon":139},[143,145],{"name":144,"role":39,"phone":25,"phoneExt":25,"email":25},"Yue Zhou, MD",{"name":146,"role":62,"phone":25,"phoneExt":25,"email":25},"Renqiang Yang",{"facility":148,"status":45,"city":149,"state":150,"zip":151,"country":49,"countryCode":50,"cosmosGeoPoint":152,"geoPoint":156,"contacts":157},"Qinghai province cardiovascular and cerebrovascular disease specialist hospital","Xining","Qinghai","810012",{"type":52,"coordinates":153},[154,155],101.75739,36.62554,{"lat":155,"lon":154},[158,160],{"name":159,"role":39,"phone":25,"phoneExt":25,"email":25},"Cun Liu, MD",{"name":159,"role":62,"phone":25,"phoneExt":25,"email":25},{"facility":162,"status":45,"city":163,"state":164,"zip":25,"country":49,"countryCode":50,"cosmosGeoPoint":165,"geoPoint":169,"contacts":170},"Zibo Central Hospital","Zibo","Shandong",{"type":52,"coordinates":166},[167,168],118.06333,36.79056,{"lat":168,"lon":167},[171,173],{"name":172,"role":39,"phone":25,"phoneExt":25,"email":25},"Hui Zhou, MD",{"name":172,"role":62,"phone":25,"phoneExt":25,"email":25},{"facility":175,"status":45,"city":176,"state":177,"zip":178,"country":49,"countryCode":50,"cosmosGeoPoint":179,"geoPoint":183,"contacts":184},"Peking University First Hospital Taiyuan Hospital","Taiyuan","Shanxi","030009",{"type":52,"coordinates":180},[181,182],112.56028,37.86944,{"lat":182,"lon":181},[185,187],{"name":186,"role":39,"phone":25,"phoneExt":25,"email":25},"Jingbo Mu, MD",{"name":188,"role":62,"phone":25,"phoneExt":25,"email":25},"Dengfeng Ma, MD",{"facility":190,"status":45,"city":191,"state":192,"zip":25,"country":49,"countryCode":50,"cosmosGeoPoint":193,"geoPoint":197,"contacts":198},"Tianjin Beichen Hospital","Tianjin","Tianjin Municipality",{"type":52,"coordinates":194},[195,196],117.17667,39.14222,{"lat":196,"lon":195},[199,201],{"name":200,"role":39,"phone":25,"phoneExt":25,"email":25},"Xuena Bi",{"name":202,"role":62,"phone":25,"phoneExt":25,"email":25},"Zhi Jia, MD",{"facility":204,"status":45,"city":191,"state":192,"zip":25,"country":49,"countryCode":50,"cosmosGeoPoint":205,"geoPoint":207,"contacts":208},"Tianjin First Central Hospital",{"type":52,"coordinates":206},[195,196],{"lat":196,"lon":195},[209,211],{"name":210,"role":39,"phone":25,"phoneExt":25,"email":25},"Yue Li, MD",{"name":212,"role":62,"phone":25,"phoneExt":25,"email":25},"Chengzhi Lu, MD",{"type":62,"investigatorFullName":214,"investigatorTitle":215,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Jianping LI","Professor","100495506","fractional-flow-reserve-to-determine-atherosclerosis-renovascular-hypertension-stenting-100495506",false,"NCT05732077","Fractional Flow Reserve to Determine Atherosclerosis Renovascular Hypertension Stenting","Fractional Flow Reserve to Determine the ApproprIateness of Percutaneous Renal Artery Intervention in Atherosclerosis Renovascular Hypertension Patients: a Pilot Randomized Trial","FAIR-Pilot","Inclusion Criteria:\n\n* With recorded hypertension, AND the blood pressure is not controlled (SBP ≥140mmHg and\u002For DBP ≥90mmHg) on 2 or more classes of anti-hypertensive drugs;\n* Evidence of renal artery stenosis and undergoing renal artery angiography;\n* Able to follow the study protocol and provide informed consent;\n* Renal artery angiography shows at least 1 main artery with stenosis of 50%-90%, AND the diameter is ≥ 4.0mm.\n\nExclusion Criteria:\n\n* SBP ≥200mmHg and\u002For DBP ≥120mmHg at the day or randomization;\n* Fibromuscular dysplasia or other non-atherosclerotic renal artery stenosis;\n* Pregnancy or unknow pregnancy status in female of childbearing potential;\n* Participation in any drug or device trial during the study period;\n* Any stroke\u002FTIA, OR with ≥70% stenosis of carotid artery;\n* Any major surgery, myocardial infarction or interventional therapy 30 days prior to study entry;\n* LVEF \\\u003C30%;\n* Comorbid condition causing life expectancy ≤1 year;\n* Allergy to contrast or any of the following: aspirin, clopidogrel;\n* Previous kidney transplant;\n* Previous renal artery bypass surgery or stent intervention;\n* Kidney size less than 8 cm measured by ultrasound;\n* Local lab serum Cr \\>3.0 mg\u002Fdl (265.2μmol\u002Fl) on the day of randomization;\n* Reference vessel size \\\u003C4 mm or \\>8 mm.","ALL","18 Years",{"count":227,"type":228},100,"ESTIMATED","INTERVENTIONAL",[231],"NA","Although randomized trials have demonstrated there is no benefit of renal-artery stenting in addition to medical therapy for patients with atherosclerosis renal artery stenosis, many patients indeed gained benefit in daily practices after stenting, such as reduction in blood pressure and recovery in renal functions. One important gap is that there is no universal standard to determine whether to stent in these patients. Fraction Flow Reserve (FFR) has been studied for many year in chronic coronary heart disease and FFR-guided revascularization strategy is known to be better than both angiography-guided revascularization and medication alone. The goal of this clinical trial is to learn whether Fraction Flow Reserve (FFR) is appropriate to determine stenting in hypertension patients with atherosclerosis renal artery stenosis. The main questions it aims to answer are:\n\n* Is it appropriate to use FFR to determine whether or not stenting for hypertension patients with atherosclerosis renal artery stenosis?\n* To provide detailed data supporting design of further trial, such as sample size calculating, cut-off value for FFR in renal artery stenosis, etc.\n\nParticipants met the inclusive\u002Fexclusive criteria will be randomized to stenting or not in the renal artery, then hyperemic FFR induced by dopamine will be measured in all participants. If FFR is ≥0.80, randomization will be applied. If FFR is \\\u003C0.80, randomization will be ignored, and stenting will be performed as planned. The blood pressure and anti-hypertensive medications will be compared before and 3 months after the procedure based on ambulatory blood pressure monitoring, all participants will be followed up for 1 year.",[234,235],"Renal Artery Stenosis Atherosclerotic","Secondary Hypertension Renal Arterial","2024-06-04",{"date":238,"type":239},"2024-06-06","ACTUAL",{"date":241,"type":239},"2023-01-31",{"date":243,"type":228},"2025-03-31",{"name":5,"class":6},13]