[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100441639":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":46,"responsibleParty":130,"collaborators":134,"id":138,"slug":139,"hasResults":140,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":144,"eligibilityCriteria":145,"healthyVolunteers":140,"sex":146,"minAge":147,"maxAge":148,"enrollmentInfo":149,"targetDuration":25,"studyType":152,"phases":153,"briefSummary":155,"conditions":156,"keywords":159,"overallStatus":49,"whyStopped":25,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":171},{"fullName":5,"class":6},"University of Leipzig","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"RDN","EXPERIMENTAL","Renal Denervation",[13],"Procedure: Renal Denervation",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham","SHAM_COMPARATOR","Sham Procedure",[19],"Procedure: Sham",[21,26],{"type":22,"name":11,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Renal denervation in patients with HFpEF and uncontrolled hypertension",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":29},"Sham Treatment. After six months, cross-over is planned in all sham-treated patients and this patients will also receive a renal denervation.",[15],[17],[31],{"name":32,"affiliation":33,"role":34},"Karl Fengler, PhD","Herzzentrum Leipzig - Universitätsklinik für Kardiologie","STUDY_CHAIR",[36,41],{"name":32,"role":37,"phone":38,"phoneExt":39,"email":40},"CONTACT","49 341","8651426","Karl.Fengler@medizin.uni-leipzig.de",{"name":42,"role":37,"phone":43,"phoneExt":44,"email":45},"Philipp Lurz, Prof. Dr.","49 6131","177251","lurzphil@uni-mainz.de",[47,67,86,102,114],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Universitätsklinikum Halle (Saale), Klinik und Poliklinik für Innere Medizin III","RECRUITING","Halle","Saxony-Anhalt","06120","Germany","DE",{"type":56,"coordinates":57},"Point",[58,59],11.97947,51.48158,{"lat":59,"lon":58},[62],{"name":63,"role":37,"phone":64,"phoneExt":65,"email":66},"Alexander Vogt, MD, PhD","+49 345","557 3134","alexander.vogt@uk-halle.de",{"facility":68,"status":49,"city":69,"state":25,"zip":70,"country":53,"countryCode":54,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"BG Klinikum Unfallkrankenhaus Berlin gGmbH","Berlin","13683",{"type":56,"coordinates":72},[73,74],13.41053,52.52437,{"lat":74,"lon":73},[77,82],{"name":78,"role":37,"phone":79,"phoneExt":80,"email":81},"Sebastian Winkler, MD, PhD","+49 30","5681 3684","sebastian.winkler@ukb.de",{"name":83,"role":37,"phone":79,"phoneExt":84,"email":85},"Leonhard Bruch, MD, PhD","5681 3601","leonhard.bruch@ukb.de",{"facility":87,"status":88,"city":89,"state":25,"zip":90,"country":53,"countryCode":54,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"Universitätsklinikum Leipzig, Klinik und Poliklinik für Kardiologie","NOT_YET_RECRUITING","Leipzig","04103",{"type":56,"coordinates":92},[93,94],12.37129,51.33962,{"lat":94,"lon":93},[97],{"name":98,"role":37,"phone":99,"phoneExt":100,"email":101},"Rolf Wachter, MD, Prof","+49 341","9720958","rolf.wachter@medizin.uni-leipzig.de",{"facility":103,"status":49,"city":89,"state":25,"zip":104,"country":53,"countryCode":54,"cosmosGeoPoint":105,"geoPoint":107,"contacts":108},"Herzzentrum Leipzig, Universitätsklinik für Kardiologie","04289",{"type":56,"coordinates":106},[93,94],{"lat":94,"lon":93},[109,112],{"name":110,"role":37,"phone":25,"phoneExt":25,"email":111},"Karl Fengler, MD, PhD","karl.fengler@medizin.uni-leipzig.de",{"name":113,"role":37,"phone":25,"phoneExt":25,"email":25},"MD, PhD",{"facility":115,"status":49,"city":116,"state":25,"zip":117,"country":53,"countryCode":54,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"Universitätsmedizin der Johannes Gutenberg Universität Mainz, Zentrum für Kardiologie \u002F Kardiologie 1","Mainz","55131",{"type":56,"coordinates":119},[120,121],8.28008,49.98185,{"lat":121,"lon":120},[124,127],{"name":125,"role":37,"phone":126,"phoneExt":44,"email":45},"Philipp Lurz, MD, Prof","+49 6131",{"name":128,"role":37,"phone":25,"phoneExt":25,"email":129},"Karl-Philipp Rommel, MD, PhD","rommelka@uni-mainz.de",{"type":131,"investigatorFullName":132,"investigatorTitle":133,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Karl Fengler","PhD",[135],{"name":136,"class":137},"ReCor Medical, Inc.","INDUSTRY","100441639","renal-denervation-to-treat-heart-failure-with-preserved-ejection-fraction-100441639",false,"NCT05030987","Renal Denervation to Treat Heart Failure With Preserved Ejection Fraction","Renal Denervation to Treat Heart Failure With Preserved Ejection Fraction - A Pilot Trial","UNLOAD-HFpEF","Inclusion Criteria:\n\n1. confirmed arterial hypertension (1-5 antihypertensive drugs without any dosage change in the preceding 4 weeks) and average systolic BP between \\>125 and ≤170 mmHg and diastolic BP ≤110 mmHg in 24h ambulatory blood pressure measurement (ABPM)\n2. HFpEF (defined by clinical signs and\u002For symptoms of heart failure, objective structural cardiac abnormalities according to the ESC (European Society of Cardiology) criteria \\[1\\], elevated NT-proBNP ≥125 pg\u002FmL and left-ventricular ejection fraction ≥55%)\n3. NYHA-Class II or III\n4. Confirmation of an elevated cardiac filling pressures (either LVEDP \\>= 16 mmHg or PCWP \\>= 15 mmHg at rest or \\>=25 mmHg during exercise) by catheterization\n5. Age 18-80 years\n6. Written informed consent\n\nExclusion Criteria:\n\n1. ≥1 main renal artery diameter \\\u003C3.0 mm\n2. main renal artery length \\\u003C 20 mm\n3. a single functioning kidney\n4. presence of abnormal kidney tumors\n5. renal artery aneurysm\n6. pre-existing renal stent or history of renal artery angioplasty\n7. fibromuscular disease of the renal arteries\n8. presence of renal artery stenosis of any origin ≥50%\n9. iliac\u002Ffemoral artery stenosis precluding femoral access for RDN\n10. fertile women (within two years of their last menstruation) without appropriate contraceptive measures (implanon, injections, oral contraceptives, intrauterine devices, partner with vasectomy) while participating in the trial (participants using a hormone-based method have to be informed of possible effects of the trial device on contraception).\n11. participation in other interventional trials\n12. patients under legal supervision or guardianship\n13. suspected lack of compliance\n14. pregnant women\n15. Presence of intracardiac pacemakers or implantable cardioverter\u002Fdefibrillators","ALL","18 Years","80 Years",{"count":150,"type":151},68,"ESTIMATED","INTERVENTIONAL",[154],"NA","Heart failure with preserved ejection fraction has a high mortality, which is contrasted by a total absence of therapy options besides symptomatic diuretic treatment. This study aims to explore the potential of renal denervation as a treatment option for heart failure with preserved ejection fraction.",[157,158],"Heart Failure With Preserved Ejection Fraction","Hypertension, Renal",[11,160,161],"Hypertension","Heart Failure with Preserved Ejection Fraction","2024-07-15",{"date":164,"type":165},"2024-07-17","ACTUAL",{"date":167,"type":165},"2021-11-30",{"date":169,"type":151},"2026-03-31",{"name":5,"class":6},5]