Vertebrobasilar Dolichoectasia Treatment With Amiloride
3 juni 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
6
Fase
- Fase 2
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Liuxun Hu
- Telefoonnummer: +8615868058299
- E-mail: 19111220090@fudan.edu.cn
Studie Contact Back-up
- Naam: Wei Zhu
- Telefoonnummer: +8615868058299
- E-mail: drzhuwei@fudan.edu.cn
Studie Locaties
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, China, 200040
- Huashan Hospital, Fudan University, Shanghai, Shanghai 200040
-
Contact:
- Wei Zhu
- Telefoonnummer: +8615868058299
- E-mail: 19111220090@fudan.edu.cn
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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.
|
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Longitudinal changes of CAWE on 5T HR-VWI in VBD following 3 and 6 months of amiloride treatment.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Incidence of ischemic stroke in VBD patients at 3, 6, and 12 months.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
1 juni 2026
Primaire voltooiing (Geschat)
1 juni 2027
Studie voltooiing (Geschat)
1 december 2027
Studieregistratiedata
Eerst ingediend
21 mei 2026
Eerst ingediend dat voldeed aan de QC-criteria
3 juni 2026
Eerst geplaatst (Werkelijk)
8 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
8 juni 2026
Laatste update ingediend die voldeed aan QC-criteria
3 juni 2026
Laatst geverifieerd
1 juni 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- KY2026-725
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .