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Vertebrobasilar Dolichoectasia Treatment With Amiloride

3 juin 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

6

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

  • Chine
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Chine, 200040
        • Huashan Hospital, Fudan University, Shanghai, Shanghai 200040
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  1. Age≥18 years, any gender;
  2. Patients with VBD confirmed by DSA/CTA/MRA;
  3. No history of VBD rupture and no surgical treatment for VBD;
  4. mRS<4;
  5. Positive plasma SGK1;
  6. No history of posterior circulation stroke, and no symptoms or signs related to VBD;
  7. No need for subsequent use of antiplatelet or statin drugs;
  8. Capable of signing an informed consent form with the accompaniment and understanding of a guardian.

Exclusion Criteria:

  1. History of malignant tumors, systemic lupus erythematosus, or gout;
  2. Pregnancy or lactation;
  3. Amiloride or sulfonamide allergy;
  4. Hydrocephalus requiring urgent surgical intervention or respiratory failure requiring life support treatment;
  5. 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;
  6. Acute cerebral infarction within the last month or definite high signal on DWI indicating acute or subacute cerebral infarction;
  7. Acute stage of intracranial hemorrhage as indicated by CT;
  8. History of VBD rupture or surgery;
  9. Presence of acute active infection (such as severe bacterial, viral or fungal infection);
  10. Uncontrolled diabetes (HbA1c≥7%);
  11. Need for subsequent use of antiplatelet or statin drugs;
  12. Systolic blood pressure< 90 mmHg or/and diastolic blood pressure< 60 mmHg;
  13. Currently participating in other clinical studies;
  14. Presence of contraindications for MRI examination;
  15. Other situations not suitable for inclusion.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Médicament: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Longitudinal changes of CAWE on 5T HR-VWI in VBD following 3 and 6 months of amiloride treatment.
Délai: 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
Longitudinal changes of SAWE on 5T HR-VWI VBD following 3 and 6 months of amiloride treatment.
Délai: 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.
Délai: 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.
Délai: 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.
3 and 6 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Incidence of ischemic stroke in VBD patients at 3, 6, and 12 months.
Délai: 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.
3, 6, and 12 months
Incidence of subarachnoid hemorrhage associated with VBD rupture in VBD patients at 3, 6, and 12 months.
Délai: 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.
3, 6, and 12 months
modified Rankin Scale in VBD patients at 3, 6, and 12 months.
Délai: 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.
3, 6, and 12 months
Five-level EuroQol five-dimensional questionnaire in VBD patients at 3, 6, and 12 months.
Délai: 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.
3, 6, and 12 months
Longitudinal changes of CAWE on 5T HR-VWI in VBD following 12 months of amiloride treatment.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
3, 6, and 12 months
Longitudinal changes of vascular tortuosity on 5T MRA in VBD following 3, 6, and 12 months of amiloride treatment.
Délai: 3, 6, and 12 months
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.
3, 6, and 12 months
Longitudinal changes of vascular elongation on 5T MRA in VBD following 3, 6, and 12 months of amiloride treatment.
Délai: 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
3, 6, and 12 months
Longitudinal changes of thrombus volume in VBD following 3, 6, and 12 months of amiloride treatment.
Délai: 3, 6, and 12 months
Using 5T HR-VWI, we quantify longitudinal changes of thrombus volume in VBD at 3, 6, and 12 months following amiloride treatment.
3, 6, and 12 months
Longitudinal changes in plasma SGK1 levels following 1, 3, 6, and 12 months of amiloride treatment in VBD patients.
Délai: 1, 3, 6, and 12 months
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
The safety of amiloride in VDB patients
Délai: 1, 3, 6, and 12 months
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.
1, 3, 6, and 12 months
The tolerability of amiloride in VDB patients
Délai: 1, 3, 6, and 12 months
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.
1, 3, 6, and 12 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Huashan Hospital

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 juin 2026

Achèvement primaire (Estimé)

1 juin 2027

Achèvement de l'étude (Estimé)

1 décembre 2027

Dates d'inscription aux études

Première soumission

21 mai 2026

Première soumission répondant aux critères de contrôle qualité

3 juin 2026

Première publication (Réel)

8 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

8 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

3 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • KY2026-725

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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