Renal Denervation Using Stereotactic Radiotherapy System for the Treatment of Refractory Hypertension
1 other identifier
interventional
18
1 country
1
Brief Summary
This study is conducted to investigate the short-term safety and preliminary efficacy of stereotactic radiotherapy for renal denervation to treat refractory hypertension.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable hypertension
Started Feb 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 11, 2019
CompletedFirst Posted
Study publicly available on registry
December 13, 2019
CompletedStudy Start
First participant enrolled
February 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedDecember 13, 2019
December 1, 2019
1.6 years
December 11, 2019
December 11, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Safety Endpoint
Safety will be assessed by incidence and evaluation of any serious adverse events using CTCAE v5.0 criteria that are related to the procedure.
90 days
Ambulatory Blood Pressure Reduction
Mean reduction in average 24-hour ambulatory blood pressure at 90 days post-treatment
90 days
Secondary Outcomes (2)
Office Blood Pressure Reduction
90 days
Number of Drug Adjustments
90 days
Study Arms (1)
stereotactic body radiotherapy (SBRT)
EXPERIMENTALNoninvasive SBRT will be delivered in a single fraction to bilateral renal arteries determined by CT-guidance.
Interventions
Image-guided stereotactic body radiation therapy
Eligibility Criteria
You may qualify if:
- Age ≥ 55 and ≤ 75 years. Systolic blood pressure of 160 mmHg or greater despite being treated with at least three hypertensive drugs for more than 3 months.
You may not qualify if:
- GFR \< 45 ml/min/1.73 m2. Known causes of secondary hypertension. Hospitalized for hypertensive crisis within 1 year. History of acute coronary syndrome or cerebrovascular accident within the last 6 months.
- Pregnancy or have a pregnancy plan. Contrast media or iodine allergy. History of abdominal radiotherapy or adhesive intestinal obstruction. Severe valvular heart disease. Stenosis \>50% or renal artery aneurysm in either renal artery. Others.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Xinhua Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200092, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yi-Gang Li, MD
Xinhua Hospital, School of Medicine, Shanghai Jiao Tong University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 11, 2019
First Posted
December 13, 2019
Study Start
February 1, 2020
Primary Completion
September 1, 2021
Study Completion
December 1, 2021
Last Updated
December 13, 2019
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will not share