[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100568079":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":36,"centralContacts":40,"locations":50,"responsibleParty":66,"collaborators":68,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":77,"sex":83,"minAge":84,"maxAge":12,"enrollmentInfo":85,"targetDuration":12,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":96,"overallStatus":52,"whyStopped":12,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"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,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"RECRUITING","Taipei","100225","Taiwan","TW",{"type":58,"coordinates":59},"Point",[60,61],121.52639,25.05306,{"lat":61,"lon":60},[64,65],{"name":38,"role":42,"phone":43,"phoneExt":12,"email":44},{"name":38,"role":39,"phone":12,"phoneExt":12,"email":12},{"type":67,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR",[69,72],{"name":70,"class":71},"Smart Health Technology Research and Development Center, National Taiwan University","UNKNOWN",{"name":73,"class":74},"Medtronic","INDUSTRY","100568079","phase-4-intraprocedural-feedback-optimized-renal-denervation-based-on-measurements-obtained-through-renal-artery-stimulation-a-randomized-controlled-trial-inform-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":86,"type":87},32,"ESTIMATED","INTERVENTIONAL",[90],"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.",[93,94,95],"Hypertension, Uncontrolled","Hypertension, Resistant","Hypertension",[95,97,98,99,100],"Renal denervation","Electric stimulation","Renal artery","Radiofrequency ablation","2024-11-04",{"date":103,"type":104},"2024-11-06","ACTUAL",{"date":106,"type":104},"2024-10-14",{"date":108,"type":87},"2028-06-30",{"name":5,"class":6},1]