[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100568079":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":36,"centralContacts":40,"locations":50,"responsibleParty":65,"collaborators":67,"id":74,"slug":12,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":75,"sex":81,"minAge":82,"maxAge":12,"enrollmentInfo":83,"targetDuration":12,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":94,"overallStatus":52,"whyStopped":12,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"National Taiwan University Hospital","OTHER",[8,13,19],{"label":9,"type":10,"description":11,"interventionNames":12},"A: Renal artery stimulation-induced systolic blood pressure rise suppressed (\u003C20 mmHg)","NO_INTERVENTION","No further renal denervation after standard renal denervation procedure",null,{"label":14,"type":15,"description":16,"interventionNames":17},"B: Re-denervation if renal artery stimulation-induced systolic blood pressure rise not suppressed","ACTIVE_COMPARATOR","Another round of renal denervation (main renal artery for positive proximal stimulation; branch artery for positive distal stimulation) after standard renal denervation. The definition of non-suppressed is systolic blood pressure rise \\>=20 mmHg compared to baseline.",[18],"Device: Radiofrequency ablation alone, re-denervation to main and\u002For branch renal artery",{"label":20,"type":21,"description":22,"interventionNames":23},"C: Control if renal artery stimulation-induced systolic blood pressure rise not suppressed","PLACEBO_COMPARATOR","No further renal denervation after standard renal denervation. The definition of non-suppressed is systolic blood pressure rise \\>=20 mmHg compared to baseline.",[24],"Procedure: Radiofrequency ablation alone, no further renal denervation",[26,31],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":12},"DEVICE","Radiofrequency ablation alone, re-denervation to main and\u002For branch renal artery","Re-denervation according to the site where renal artery stimulation can induce systolic blood pressure rise of \\>= 20 mmHg. Main renal artery denervation if proximal main renal artery stimulation positive, while branch renal artery denervation if distal main renal artery stimulation positive.",[14],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":12},"PROCEDURE","Radiofrequency ablation alone, no further renal denervation","No further renal denervation after standard renal denervation even renal artery stimulation-induced systolic blood pressure rise \\>= 20 mmHg",[20],[37],{"name":38,"affiliation":5,"role":39},"Tzung-Dau Wang, MD, PhD","PRINCIPAL_INVESTIGATOR",[41,45],{"name":38,"role":42,"phone":43,"phoneExt":12,"email":44},"CONTACT","886-972651070","tdwang@ntu.edu.tw",{"name":46,"role":42,"phone":47,"phoneExt":48,"email":49},"Ya-Chun Chen, BS","886-2-23123456","265877","yachun0411@gmai.com",[51],{"facility":5,"status":52,"city":53,"state":12,"zip":54,"country":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"RECRUITING","Taipei","100225","Taiwan",{"type":57,"coordinates":58},"Point",[59,60],121.52639,25.05306,{"lat":60,"lon":59},[63,64],{"name":38,"role":42,"phone":43,"phoneExt":12,"email":44},{"name":38,"role":39,"phone":12,"phoneExt":12,"email":12},{"type":66,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR",[68,71],{"name":69,"class":70},"Smart Health Technology Research and Development Center, National Taiwan University","UNKNOWN",{"name":72,"class":73},"Medtronic","INDUSTRY","100568079",false,"NCT06676553","INtraprocedural Feedback-Optimized Renal Denervation Based on Measurements Obtained Through Renal Artery Stimulation: a Randomized Controlled Trial (INFORM)","INtraprocedural Feedback-Optimized Renal Denervation Based on Measurements Obtained Through Renal Artery Stimulation: a Randomized Controlled Proof-of-concept Trial to Assess Whether Renal Denervation Guided by Renal Artery Stimulation Outperforms Conventional Renal Denervation in 6-month Ambulatory Blood Pressure Reductions","INFORM","Inclusion Criteria:\n\n* Patients with hypertension and are willing to undergo renal denervation.\n* Patients are treated with antihypertensive medications, or with an office systolic blood pressure (SBP) \\>140 mm Hg or diastolic blood pressure (DBP) \\>90 mm Hg, and 24-hour SBP of \\>130 mmHg or DBP \\>80 mm Hg, irrespective of antihypertensive treatment.\n\nExclusion Criteria:\n\n* An unsuitable renal artery anatomy for renal denervation, assessed by computed tomographic angiography (main renal artery lumen diameter \\\u003C3 mm or a total length \\\u003C20 mm).\n* Secondary hypertension, including hyperaldosteronism, pheochromocytoma, and renal artery stenosis (\\>50% stenosis in one or both arteries).","ALL","18 Years",{"count":84,"type":85},32,"ESTIMATED","INTERVENTIONAL",[88],"PHASE4","Our previous study (Huang HC, Pan HY, Wang TD, Circ Cardiovasc Interv 2023;16:e012779) demonstrated that when renal artery stimulation continues to trigger systolic blood pressure increases (\\>=20 mmHg increase compared to baseline) after the initial procedure, patients show poor blood pressure reduction 6 months following renal denervation. Based on this finding, we designed a proof-of-concept trial comparing two approaches: a guided strategy versus conventional renal denervation. In the guided strategy, we perform additional ablations of main and\u002For branch renal arteries if immediate post-procedure stimulation still elevates systolic blood pressure (\\>=20 mmHg increase compared to baseline). The conventional approach involves no repeat procedures. This trial aims to determine whether the guided strategy leads to better clinical outcomes, measured by 6-month ambulatory blood pressure changes, and to establish the value of using intraprocedural feedback to assess and guide renal denervation treatment.",[91,92,93],"Hypertension, Uncontrolled","Hypertension, Resistant","Hypertension",[93,95,96,97,98],"Renal denervation","Electric stimulation","Renal artery","Radiofrequency ablation","2024-11-04",{"date":101,"type":102},"2024-11-06","ACTUAL",{"date":104,"type":102},"2024-10-14",{"date":106,"type":85},"2028-06-30",{"name":5,"class":6},1]