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Enhanced Versus Standard Blood Pressure Lowering on Intracranial Aneurysm Rupture or Growth

Status: Completed
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this randomized controlled trial is to evaluate the benefits and safety of controlled hypotension in Chinese patients with unruptured intracranial aneurysms(UIA). The main questions it aims to answer are: * To provide high-level evidence of the benefits and safety of controlled hypotension in patients with UIA. * To provide evidence-based medical evidence for blood pressure control of patients with UIA in neurosurgery, and promote the progress of accurate individual management of patients. In this study, the main intervention is enhanced blood pressure lowering in patients with UIA. All Patients will be randomly assigned to either the standard blood pressure lowering (SBPL) group or the enhanced blood pressure lowering (EBPL) group.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Age 18-75.

• Chinese ethnicity.

• Unruptured saccular intracranial aneurysm (UIA) identified by computational tomography angiography, magnetic resonance angiography or digital subtraction angiography.

‣ Maximal size of UIA at largest dimension \< 7 mm

⁃ The morphology of UIA is regular (no bleb(s) or secondary aneurysm(s) protruding from the UIA fundus or bi-/ multi-lobular UIA fundus)

⁃ UIA receiving conservative treatment

• History of primary hypertension (as diagnosed per standard of care)

• Systolic blood pressure (SBP) on 2 consecutive visits:

• SBP: 130-180 mmHg on 0 or 1 antihypertensive medication. SBP: 130-170 mmHg on up to 2 antihypertensive medications. SBP: 130-160 mmHg on up to 3 antihypertensive medications. SBP: 130-150 mmHg on up to 4 antihypertensive medications

• Good medication adherence (Morisky Medication Adherence Scale ≥6)

• Obtain informed consent from patient or legal representative

Locations
Other Locations
China
Capital Medical University Affiliated Beijing Tiantan Hospital
Beijing
Time Frame
Start Date: 2023-07-01
Completion Date: 2026-01-19
Participants
Target number of participants: 577
Treatments
Experimental: standard blood pressure lowering (SBPL) group
Experimental: enhanced blood pressure lowering (EBPL) group
Related Therapeutic Areas
Sponsors
Collaborators: Binzhou Medical University, Beijing Anzhen Hospital, Guangzhou Red Cross Hospital, RenJi Hospital, Beijing Friendship Hospital, Beijing Chao Yang Hospital, Jiangnan University Medical Center, First Affiliated Hospital of Fujian Medical University
Leads: Beijing Tiantan Hospital

This content was sourced from clinicaltrials.gov