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.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Longitudinal changes of CAWE on 5T HR-VWI in VBD following 3 and 6 months of amiloride treatment. — 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.
Longitudinal changes of SAWE on 5T HR-VWI VBD following 3 and 6 months of amiloride treatment. — 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.
Longitudinal changes of FAWE in VBD on 5T HR-VWI 3 and 6 months of amiloride treatment. — 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.
Longitudinal changes of WEVR on 5T HR-VWI in VBD following 3 and 6 months of amiloride treatment. — 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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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