[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643786":3},{"organization":4,"outcomesModule":7,"designInfo":72,"detailedDescription":71,"studyPopulation":71,"armGroups":78,"interventions":85,"overallOfficials":71,"centralContacts":91,"locations":100,"responsibleParty":116,"collaborators":71,"id":119,"slug":71,"hasResults":120,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":71,"eligibilityCriteria":124,"healthyVolunteers":120,"sex":125,"minAge":126,"maxAge":71,"enrollmentInfo":127,"targetDuration":71,"studyType":130,"phases":131,"briefSummary":133,"conditions":134,"keywords":71,"overallStatus":136,"whyStopped":71,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":146},{"fullName":5,"class":6},"Huashan Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":22,"otherOutcomes":71},[9,13,16,19],{"measure":10,"description":11,"timeFrame":12},"Longitudinal changes of CAWE on 5T HR-VWI in VBD following 3 and 6 months of amiloride treatment.","Using 5T HR-VWI, we quantify longitudinal changes of vascular CAWE (3D circumferential arterial wall enhancement: mean signal intensity in T1+Gd images) at 3 and 6 months following initiation of amiloride therapy. The primary objective of this study is to determine whether amiloride exerts an anti-inflammatory effect on the diseased vertebrobasilar arterial wall in patients with VBD.","3 and 6 months",{"measure":14,"description":15,"timeFrame":12},"Longitudinal changes of SAWE on 5T HR-VWI VBD following 3 and 6 months of amiloride treatment.","Using 5T HR-VWI, we quantify longitudinal changes of vascular SAWE (specific contrast uptake arterial wall enhancement: the difference in mean signal intensity between T1 and T1+Gd) at 3 and 6 months following initiation of amiloride therapy. The primary objective of this study is to determine whether amiloride exerts an anti-inflammatory effect on the diseased vertebrobasilar arterial wall in patients with VBD.",{"measure":17,"description":18,"timeFrame":12},"Longitudinal changes of FAWE in VBD on 5T HR-VWI 3 and 6 months of amiloride treatment.","Using 5T HR-VWI, we quantify longitudinal changes of vascular FAWE (focal arterial wall enhancement: areas of the diseased artery with increased AWE) at 3 and 6 months following initiation of amiloride therapy. The primary objective of this study is to determine whether amiloride exerts an anti-inflammatory effect on the diseased vertebrobasilar arterial wall in patients with VBD.",{"measure":20,"description":21,"timeFrame":12},"Longitudinal changes of WEVR on 5T HR-VWI in VBD following 3 and 6 months of amiloride treatment.","Using 5T HR-VWI, we quantify longitudinal changes of vascular WEVR (3D arterial wall enhancement volume rate) at 3 and 6 months following initiation of amiloride therapy. The primary objective of this study is to determine whether amiloride exerts an anti-inflammatory effect on the diseased vertebrobasilar arterial wall in patients with VBD.",[23,27,30,33,36,40,43,46,49,53,56,59,62,65,68],{"measure":24,"description":25,"timeFrame":26},"Longitudinal changes of CAWE on 5T HR-VWI in VBD following 12 months of amiloride treatment.","Using 5T HR-VWI, we quantify longitudinal changes of vascular CAWE (3D circumferential arterial wall enhancement: mean signal intensity in T1+Gd images) at 12 months following initiation of amiloride therapy. The primary objective of this study is to determine whether amiloride exerts an anti-inflammatory effect on the diseased vertebrobasilar arterial wall in patients with VBD.","12 months",{"measure":28,"description":29,"timeFrame":26},"Longitudinal changes of SAWE on 5T HR-VWI VBD following 12 months of amiloride treatment.","Using 5T HR-VWI, we quantify longitudinal changes of vascular SAWE (specific contrast uptake arterial wall enhancement: the difference in mean signal intensity between T1 and T1+Gd) at 12 months following initiation of amiloride therapy. The primary objective of this study is to determine whether amiloride exerts an anti-inflammatory effect on the diseased vertebrobasilar arterial wall in patients with VBD.",{"measure":31,"description":32,"timeFrame":26},"Longitudinal changes of FAWE on 5T HR-VWI VBD 12 months of amiloride treatment.","Using 5T HR-VWI, we quantify longitudinal changes of vascular FAWE (focal arterial wall enhancement: areas of the diseased artery with increased AWE) at 12 months following initiation of amiloride therapy. The primary objective of this study is to determine whether amiloride exerts an anti-inflammatory effect on the diseased vertebrobasilar arterial wall in patients with VBD.",{"measure":34,"description":35,"timeFrame":26},"Longitudinal changes of WEVR on 5T HR-VWI in VBD following 12 months of amiloride treatment.","Using 5T HR-VWI, we quantify longitudinal changes of vascular WEVR (3D arterial wall enhancement volume rate) at 12 months following initiation of amiloride therapy. The primary objective of this study is to determine whether amiloride exerts an anti-inflammatory effect on the diseased vertebrobasilar arterial wall in patients with VBD.",{"measure":37,"description":38,"timeFrame":39},"Longitudinal changes of vascular dilation on 5T MRA in VBD following 3, 6, and 12 months of amiloride treatment.","Using 5T MRA, we quantify longitudinal changes of dilation(maximum diameter of the intracranial segment of the vertebral artery and basilar artery) of diseased vessel in VBD at 3, 6, and 12 months following amiloride treatment.","3, 6, and 12 months",{"measure":41,"description":42,"timeFrame":39},"Longitudinal changes of vascular tortuosity on 5T MRA in VBD following 3, 6, and 12 months of amiloride treatment.","Using 5T MRA, we quantify longitudinal changes of tortuosity(displacement distance of the intracranial segment of the vertebral artery and basilar artery) of diseased vessel in VBD at 3, 6, and 12 months following amiloride treatment.",{"measure":44,"description":45,"timeFrame":39},"Longitudinal changes of vascular elongation on 5T MRA in VBD following 3, 6, and 12 months of amiloride treatment.","Using 5T MRA, we quantify longitudinal changes of elongation(length of the basilar artery) of diseased vessel in VBD at 3, 6, and 12 months following amiloride treatment",{"measure":47,"description":48,"timeFrame":39},"Longitudinal changes of thrombus volume in VBD following 3, 6, and 12 months of amiloride treatment.","Using 5T HR-VWI, we quantify longitudinal changes of thrombus volume in VBD at 3, 6, and 12 months following amiloride treatment.",{"measure":50,"description":51,"timeFrame":52},"Longitudinal changes in plasma SGK1 levels following 1, 3, 6, and 12 months of amiloride treatment in VBD patients.","Longitudinal changes in plasma SGK1 levels (quantitative analysis of plasma SGK1 was performed via western blot) following 1, 3, 6, and 12 months of amiloride treatment in VBD patients.","1, 3, 6, and 12 months",{"measure":54,"description":55,"timeFrame":39},"Incidence of ischemic stroke in VBD patients at 3, 6, and 12 months.","Incidence of ischemic stroke(newly developed infarct lesion confirmed by CT\u002FMRI after onset of relevant symptoms\u002Fsigns or newly developed infarct lesion confirmed by follow-up MRI at 3, 6, or 12 months) in VBD patients at 3, 6, and 12 months.",{"measure":57,"description":58,"timeFrame":39},"Incidence of subarachnoid hemorrhage associated with VBD rupture in VBD patients at 3, 6, and 12 months.","Incidence of subarachnoid hemorrhage associated with VBD rupture(newly developed subarachnoid hemorrhage confirmed by CT\u002FMRI after onset of relevant symptoms\u002Fsigns or newly developed subarachnoid hemorrhage confirmed by follow-up MRI at 3, 6, or 12 months) at 3, 6, and 12 months.",{"measure":60,"description":61,"timeFrame":39},"modified Rankin Scale in VBD patients at 3, 6, and 12 months.","modified Rankin Scale (mRS), a 7-level, clinician-reported, measure of global disability is measured in VBD patients at 3, 6, and 12 months.",{"measure":63,"description":64,"timeFrame":39},"Five-level EuroQol five-dimensional questionnaire in VBD patients at 3, 6, and 12 months.","Five-level EuroQol five-dimensional questionnaire(EQ-5D-5L), a 5-level, measure of quality of life, is performed in VBD patients at 3, 6, and 12 months.",{"measure":66,"description":67,"timeFrame":52},"The safety of amiloride in VDB patients","A serious adverse event (SAE) is any untoward medical occurrence that meets one or more of the following criteria, regardless of suspected causal relationship to the study intervention: (1) results in death; (2) is life-threatening; (3) requires inpatient hospitalization or prolongation of existing hospitalization; (4) results in persistent or significant disability or incapacity, or substantially disrupts normal life functions; or (5) constitutes an important medical event that, based on appropriate medical judgment, may jeopardize the patient's health or require medical or surgical intervention to prevent one or more of the outcomes listed in (1)-(4). SAEs will be actively monitored and systematically assessed at all scheduled follow-up visits (at 1, 3, 6, and 12 months post-baseline). In addition, participants are instructed to report any suspected SAE immediately to the study team via a dedicated 24\u002F7 telephone hotline. To ensure timely detection and documentation.",{"measure":69,"description":70,"timeFrame":52},"The tolerability of amiloride in VDB patients","Based on prior clinical experience and amiloride trial reports, adverse events (AEs) include dizziness, headache, anorexia, nausea, abdominal distension, fluctuations in blood pressure, and mild electrolyte disturbances (such as hyperkalemia or hypokalemia). In addition, arrhythmias (hyperkalemia-related), allergic reactions (rash, dyspnea), and worsening renal function have been observed. Unanticipated Adverse Device Effect (UADE): Any serious adverse effect on health or safety, life-threatening event, or death caused by or associated with amiloride, where the nature, severity, or incidence of such effect, event, or death was not previously identified in the investigational plan; or any other unanticipated serious problem related to amiloride that concerns the rights, safety, or welfare of subjects.",null,{"allocation":73,"interventionModel":74,"interventionModelDescription":71,"primaryPurpose":75,"observationalModel":71,"timePerspective":71,"maskingInfo":76},"NA","SINGLE_GROUP","TREATMENT",{"masking":77,"maskingDescription":71,"whoMasked":71},"NONE",[79],{"label":80,"type":81,"description":82,"interventionNames":83},"amiloride","EXPERIMENTAL","Participants will receive oral amiloride hydrochlorothiazide 1 tablet per day (contains 2.5 mg of amiloride and 25 mg of hydrochlorothiazide per tablet) continuously for 6 months.",[84],"Drug: Amiloride hydrochlorothiazide",[86],{"type":87,"name":88,"description":89,"armGroupLabels":90,"otherNames":71},"DRUG","Amiloride hydrochlorothiazide","Amiloride, a potassium-sparing diuretic, also an mTORC2 inhibitor, has been widely utilized in clinical settings. It can be employed as an adjunctive agent for hypertension management and has been investigated in completed clinical trials targeting resistant hypertension.",[80],[92,97],{"name":93,"role":94,"phone":95,"phoneExt":71,"email":96},"Liuxun Hu","CONTACT","+8615868058299","19111220090@fudan.edu.cn",{"name":98,"role":94,"phone":95,"phoneExt":71,"email":99},"Wei Zhu","drzhuwei@fudan.edu.cn",[101],{"facility":102,"status":71,"city":103,"state":104,"zip":105,"country":106,"countryCode":107,"cosmosGeoPoint":108,"geoPoint":113,"contacts":114},"Huashan Hospital, Fudan University, Shanghai, Shanghai 200040","Shanghai","Shanghai Municipality","200040","China","CN",{"type":109,"coordinates":110},"Point",[111,112],121.45806,31.22222,{"lat":112,"lon":111},[115],{"name":98,"role":94,"phone":95,"phoneExt":71,"email":96},{"type":117,"investigatorFullName":98,"investigatorTitle":118,"investigatorAffiliation":5,"oldNameTitle":71,"oldOrganization":71},"PRINCIPAL_INVESTIGATOR","Principal Investigator","100643786",false,"NCT07634068","Vertebrobasilar Dolichoectasia Treatment With Amiloride","Vertebrobasilar Dolichoectasia Treatment With Amiloride: a Pilot Study Based On 5.0 T MRI","Inclusion Criteria:\n\n1. Age≥18 years, any gender;\n2. Patients with VBD confirmed by DSA\u002FCTA\u002FMRA;\n3. No history of VBD rupture and no surgical treatment for VBD;\n4. mRS\\\u003C4;\n5. Positive plasma SGK1;\n6. No history of posterior circulation stroke, and no symptoms or signs related to VBD;\n7. No need for subsequent use of antiplatelet or statin drugs;\n8. Capable of signing an informed consent form with the accompaniment and understanding of a guardian.\n\nExclusion Criteria:\n\n1. History of malignant tumors, systemic lupus erythematosus, or gout;\n2. Pregnancy or lactation;\n3. Amiloride or sulfonamide allergy;\n4. Hydrocephalus requiring urgent surgical intervention or respiratory failure requiring life support treatment;\n5. Abnormal hepatic and\u002For renal function (serum transaminase \\> 40 U\u002FL; serum creatinine \\> 110 μmol\u002FL); and\u002For abnormal white blood cells\u002Fplatelets (white blood cells count \\\u003C 3.5 × 10⁹\u002FL or \\> 9.5 × 10⁹\u002FL; platelets count \\\u003C 100 × 10⁹\u002FL or \\> 300 × 10⁹\u002FL); hyperkalemia, hypokalemia, hyponatremia, or hypercalcemia;\n6. Acute cerebral infarction within the last month or definite high signal on DWI indicating acute or subacute cerebral infarction;\n7. Acute stage of intracranial hemorrhage as indicated by CT;\n8. History of VBD rupture or surgery;\n9. Presence of acute active infection (such as severe bacterial, viral or fungal infection);\n10. Uncontrolled diabetes (HbA1c≥7%);\n11. Need for subsequent use of antiplatelet or statin drugs;\n12. Systolic blood pressure\\\u003C 90 mmHg or\u002Fand diastolic blood pressure\\\u003C 60 mmHg;\n13. Currently participating in other clinical studies;\n14. Presence of contraindications for MRI examination;\n15. Other situations not suitable for inclusion.","ALL","18 Years",{"count":128,"type":129},6,"ESTIMATED","INTERVENTIONAL",[132],"PHASE2","The aim of this pilot study is to assess the efficacy of amiloride in reducing wall enhancement in vertebrobasilar dolichoectasia(VBD) on high-resolution magnetic resonance vessel wall imaging(HR-VWI) via anti-inflammatory mechanisms, clarify the efficacy of amiloride in delaying the progression of VBD, evaluate the safety of amiloride in the treatment of VBD.",[135],"Vertebrobasilar Dolichoectasia","NOT_YET_RECRUITING","2026-06-03",{"date":139,"type":140},"2026-06-08","ACTUAL",{"date":142,"type":129},"2026-06",{"date":144,"type":129},"2027-12",{"name":5,"class":6},1]