Hypertension
Conditions
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.
Detailed description
This will be a single centre, single arm, prospective cohort study. Patients with refractory hypertension will receive single fraction stereotactic radiotherapy for renal denervation. The study has been designed in a careful and stepwise dose escalation fashion in order to minimize the potential risks associated with this innovative technique. The dose escalation is guided by 3+3 algorithm to ensure more patients will be spared dose limiting toxicities and more patients will be entered on the dose level that will be chosen as optimal dose of maximal effect. Low dosing levels with established safety profile will first be applied before administering higher dosing levels based on preclinical studies. Safety is the primary endpoint of this study. Safety will be assessed by incidence and evaluation of any serious adverse events using CTCAE v5.0 criteria associated with the procedure through 90 days. Efficacy will be evaluated by assessing mean reduction in average 24-hour ambulatory blood pressure at 90 days post-treatment.
Interventions
RADIATIONstereotactic body radiotherapy (SBRT)
Image-guided stereotactic body radiation therapy
Sponsors
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Endpoint | 90 days | Safety will be assessed by incidence and evaluation of any serious adverse events using CTCAE v5.0 criteria that are related to the procedure. |
| Ambulatory Blood Pressure Reduction | 90 days | Mean reduction in average 24-hour ambulatory blood pressure at 90 days post-treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Office Blood Pressure Reduction | 90 days | Mean reduction in office blood pressure at 90 days post-treatment |
| Number of Drug Adjustments | 90 days | Number of drug adjustments for hypertension through 90 days after treatment |
Countries
China
Contacts
Primary ContactYi-Gang Li, MD
Backup ContactXingxing Cai, MD&PhD
Outcome results
None listed