Vertebrobasilar Dolichoectasia Treatment With Amiloride
2026年6月3日 更新者：Wei Zhu、Huashan Hospital
Vertebrobasilar Dolichoectasia Treatment With Amiloride: a Pilot Study Based On 5.0 T MRI
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.
研究概览
研究类型
介入性
注册 (估计的)
6
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Liuxun Hu
- 电话号码：+8615868058299
- 邮箱：19111220090@fudan.edu.cn
研究联系人备份
- 姓名：Wei Zhu
- 电话号码：+8615868058299
- 邮箱：drzhuwei@fudan.edu.cn
学习地点
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Shanghai Municipality
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Shanghai、Shanghai Municipality、中国、200040
- Huashan Hospital, Fudan University, Shanghai, Shanghai 200040
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接触：
- Wei Zhu
- 电话号码：+8615868058299
- 邮箱：19111220090@fudan.edu.cn
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Age≥18 years, any gender;
- Patients with VBD confirmed by DSA/CTA/MRA;
- No history of VBD rupture and no surgical treatment for VBD;
- mRS<4;
- Positive plasma SGK1;
- No history of posterior circulation stroke, and no symptoms or signs related to VBD;
- No need for subsequent use of antiplatelet or statin drugs;
- Capable of signing an informed consent form with the accompaniment and understanding of a guardian.
Exclusion Criteria:
- History of malignant tumors, systemic lupus erythematosus, or gout;
- Pregnancy or lactation;
- Amiloride or sulfonamide allergy;
- Hydrocephalus requiring urgent surgical intervention or respiratory failure requiring life support treatment;
- Abnormal hepatic and/or renal function (serum transaminase > 40 U/L; serum creatinine > 110 μmol/L); and/or abnormal white blood cells/platelets (white blood cells count < 3.5 × 10⁹/L or > 9.5 × 10⁹/L; platelets count < 100 × 10⁹/L or > 300 × 10⁹/L); hyperkalemia, hypokalemia, hyponatremia, or hypercalcemia;
- Acute cerebral infarction within the last month or definite high signal on DWI indicating acute or subacute cerebral infarction;
- Acute stage of intracranial hemorrhage as indicated by CT;
- History of VBD rupture or surgery;
- Presence of acute active infection (such as severe bacterial, viral or fungal infection);
- Uncontrolled diabetes (HbA1c≥7%);
- Need for subsequent use of antiplatelet or statin drugs;
- Systolic blood pressure< 90 mmHg or/and diastolic blood pressure< 60 mmHg;
- Currently participating in other clinical studies;
- Presence of contraindications for MRI examination;
- Other situations not suitable for inclusion.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：amiloride
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.
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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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Longitudinal changes of CAWE on 5T HR-VWI in VBD following 3 and 6 months of amiloride treatment.
大体时间：3 and 6 months
|
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
|
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Longitudinal changes of SAWE on 5T HR-VWI VBD following 3 and 6 months of amiloride treatment.
大体时间：3 and 6 months
|
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.
|
3 and 6 months
|
|
Longitudinal changes of FAWE in VBD on 5T HR-VWI 3 and 6 months of amiloride treatment.
大体时间：3 and 6 months
|
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.
|
3 and 6 months
|
|
Longitudinal changes of WEVR on 5T HR-VWI in VBD following 3 and 6 months of amiloride treatment.
大体时间：3 and 6 months
|
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.
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3 and 6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incidence of ischemic stroke in VBD patients at 3, 6, and 12 months.
大体时间：3, 6, and 12 months
|
Incidence of ischemic stroke(newly developed infarct lesion confirmed by CT/MRI after onset of relevant symptoms/signs 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.
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3, 6, and 12 months
|
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Incidence of subarachnoid hemorrhage associated with VBD rupture in VBD patients at 3, 6, and 12 months.
大体时间：3, 6, and 12 months
|
Incidence of subarachnoid hemorrhage associated with VBD rupture(newly developed subarachnoid hemorrhage confirmed by CT/MRI after onset of relevant symptoms/signs or newly developed subarachnoid hemorrhage confirmed by follow-up MRI at 3, 6, or 12 months) at 3, 6, and 12 months.
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3, 6, and 12 months
|
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modified Rankin Scale in VBD patients at 3, 6, and 12 months.
大体时间：3, 6, and 12 months
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modified Rankin Scale (mRS), a 7-level, clinician-reported, measure of global disability is measured in VBD patients at 3, 6, and 12 months.
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3, 6, and 12 months
|
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Five-level EuroQol five-dimensional questionnaire in VBD patients at 3, 6, and 12 months.
大体时间：3, 6, and 12 months
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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.
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3, 6, and 12 months
|
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Longitudinal changes of CAWE on 5T HR-VWI in VBD following 12 months of amiloride treatment.
大体时间：12 months
|
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
|
|
Longitudinal changes of SAWE on 5T HR-VWI VBD following 12 months of amiloride treatment.
大体时间：12 months
|
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.
|
12 months
|
|
Longitudinal changes of FAWE on 5T HR-VWI VBD 12 months of amiloride treatment.
大体时间：12 months
|
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.
|
12 months
|
|
Longitudinal changes of WEVR on 5T HR-VWI in VBD following 12 months of amiloride treatment.
大体时间：12 months
|
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.
|
12 months
|
|
Longitudinal changes of vascular dilation on 5T MRA in VBD following 3, 6, and 12 months of amiloride treatment.
大体时间：3, 6, and 12 months
|
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.
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3, 6, and 12 months
|
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Longitudinal changes of vascular tortuosity on 5T MRA in VBD following 3, 6, and 12 months of amiloride treatment.
大体时间：3, 6, and 12 months
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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.
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3, 6, and 12 months
|
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Longitudinal changes of vascular elongation on 5T MRA in VBD following 3, 6, and 12 months of amiloride treatment.
大体时间：3, 6, and 12 months
|
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
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3, 6, and 12 months
|
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Longitudinal changes of thrombus volume in VBD following 3, 6, and 12 months of amiloride treatment.
大体时间：3, 6, and 12 months
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Using 5T HR-VWI, we quantify longitudinal changes of thrombus volume in VBD at 3, 6, and 12 months following amiloride treatment.
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3, 6, and 12 months
|
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Longitudinal changes in plasma SGK1 levels following 1, 3, 6, and 12 months of amiloride treatment in VBD patients.
大体时间：1, 3, 6, and 12 months
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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.
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1, 3, 6, and 12 months
|
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The safety of amiloride in VDB patients
大体时间：1, 3, 6, and 12 months
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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 24/7 telephone hotline.
To ensure timely detection and documentation.
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1, 3, 6, and 12 months
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The tolerability of amiloride in VDB patients
大体时间：1, 3, 6, and 12 months
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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.
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1, 3, 6, and 12 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年6月1日
初级完成 (估计的)
2027年6月1日
研究完成 (估计的)
2027年12月1日
研究注册日期
首次提交
2026年5月21日
首先提交符合 QC 标准的
2026年6月3日
首次发布 (实际的)
2026年6月8日
研究记录更新
最后更新发布 (实际的)
2026年6月8日
上次提交的符合 QC 标准的更新
2026年6月3日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.