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Not yet recruiting NCT07634068

Vertebrobasilar Dolichoectasia Treatment With Amiloride

Phase II Interventional Vertebrobasilar Dolichoectasia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Amiloride hydrochlorothiazide.
Who it may be relevant to
Registry conditions: Vertebrobasilar Dolichoectasia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Vertebrobasilar Dolichoectasia Treatment With Amiloride: a Pilot Study Based On 5.0 T MRI

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Longitudinal changes of CAWE on 5T HR-VWI in VBD following 3 and 6 months of amiloride treatment. [Time frame: 3 and 6 months]
  • Longitudinal changes of SAWE on 5T HR-VWI VBD following 3 and 6 months of amiloride treatment. [Time frame: 3 and 6 months]
  • Longitudinal changes of FAWE in VBD on 5T HR-VWI 3 and 6 months of amiloride treatment. [Time frame: 3 and 6 months]
  • Longitudinal changes of WEVR on 5T HR-VWI in VBD following 3 and 6 months of amiloride treatment. [Time frame: 3 and 6 months]
Secondary outcome measures (12)
  • Longitudinal changes of CAWE on 5T HR-VWI in VBD following 12 months of amiloride treatment. [Time frame: 12 months]
  • Longitudinal changes of SAWE on 5T HR-VWI VBD following 12 months of amiloride treatment. [Time frame: 12 months]
  • Longitudinal changes of FAWE on 5T HR-VWI VBD 12 months of amiloride treatment. [Time frame: 12 months]
  • Longitudinal changes of WEVR on 5T HR-VWI in VBD following 12 months of amiloride treatment. [Time frame: 12 months]
  • Longitudinal changes of vascular dilation on 5T MRA in VBD following 3, 6, and 12 months of amiloride treatment. [Time frame: 3, 6, and 12 months]
  • Longitudinal changes of vascular tortuosity on 5T MRA in VBD following 3, 6, and 12 months of amiloride treatment. [Time frame: 3, 6, and 12 months]
  • Longitudinal changes of vascular elongation on 5T MRA in VBD following 3, 6, and 12 months of amiloride treatment. [Time frame: 3, 6, and 12 months]
  • Longitudinal changes of thrombus volume in VBD following 3, 6, and 12 months of amiloride treatment. [Time frame: 3, 6, and 12 months]
  • Longitudinal changes in plasma SGK1 levels following 1, 3, 6, and 12 months of amiloride treatment in VBD patients. [Time frame: 1, 3, 6, and 12 months]
  • Incidence of ischemic stroke in VBD patients at 3, 6, and 12 months. [Time frame: 3, 6, and 12 months]
  • Incidence of subarachnoid hemorrhage associated with VBD rupture in VBD patients at 3, 6, and 12 months. [Time frame: 3, 6, and 12 months]
  • modified Rankin Scale in VBD patients at 3, 6, and 12 months. [Time frame: 3, 6, and 12 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Huashan Hospital, Fudan University, Shanghai, Shanghai 200040 — Shanghai

Identifiers

NCT: NCT07634068 · KY2026-725

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗