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Vertebrobasilar Dolichoectasia Treatment With Amiloride

3. juni 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

6

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Kina
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina, 200040
        • Huashan Hospital, Fudan University, Shanghai, Shanghai 200040
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Longitudinal changes of CAWE on 5T HR-VWI in VBD following 3 and 6 months of amiloride treatment.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of ischemic stroke in VBD patients at 3, 6, and 12 months.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Huashan Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. juni 2027

Studieafslutning (Anslået)

1. december 2027

Datoer for studieregistrering

Først indsendt

21. maj 2026

Først indsendt, der opfyldte QC-kriterier

3. juni 2026

Først opslået (Faktiske)

8. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • KY2026-725

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Kliniske forsøg med Vertebrobasilar Dolichoectasia

Kliniske forsøg med Amiloride hydrochlorothiazide

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