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.
調査の概要
研究の種類
介入
入学 (推定)
6
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Liuxun Hu
- 電話番号：+8615868058299
- メール：19111220090@fudan.edu.cn
研究連絡先のバックアップ
- 名前：Wei Zhu
- 電話番号：+8615868058299
- メール：drzhuwei@fudan.edu.cn
研究場所
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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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コンタクト：
- Wei Zhu
- 電話番号：+8615868058299
- メール：19111220090@fudan.edu.cn
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Longitudinal changes of CAWE on 5T HR-VWI in VBD following 3 and 6 months of amiloride treatment.
時間枠：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.
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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.
時間枠：3 and 6 months
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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.
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3 and 6 months
|
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Longitudinal changes of FAWE in VBD on 5T HR-VWI 3 and 6 months of amiloride treatment.
時間枠：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.
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3 and 6 months
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Longitudinal changes of WEVR on 5T HR-VWI in VBD following 3 and 6 months of amiloride treatment.
時間枠：3 and 6 months
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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
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Incidence of ischemic stroke in VBD patients at 3, 6, and 12 months.
時間枠：3, 6, and 12 months
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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.
時間枠：3, 6, and 12 months
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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.
時間枠：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.
時間枠：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.
時間枠：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.
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12 months
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Longitudinal changes of SAWE on 5T HR-VWI VBD following 12 months of amiloride treatment.
時間枠：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.
時間枠：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.
時間枠：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
|
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Longitudinal changes of vascular dilation on 5T MRA in VBD following 3, 6, and 12 months of amiloride treatment.
時間枠：3, 6, and 12 months
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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.
時間枠：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.
時間枠：3, 6, and 12 months
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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.
時間枠：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.
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
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スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年6月1日
一次修了 (推定)
2027年6月1日
研究の完了 (推定)
2027年12月1日
試験登録日
最初に提出
2026年5月21日
QC基準を満たした最初の提出物
2026年6月3日
最初の投稿 (実際)
2026年6月8日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月8日
QC基準を満たした最後の更新が送信されました
2026年6月3日
最終確認日
2026年6月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。