Renal Denervation Using Stereotactic Radiotherapy System for the Treatment of Refractory Hypertension

Not Applicable

• Conditions: Hypertension
• Interventions: Radiation: stereotactic body radiotherapy (SBRT)

• Registration Number: NCT04198155
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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.

Study Timeline

• Status Verified: 2019-12
• Study First Submitted: 2019-12-11
• Study First Submitted QC: 2019-12-11
• Last Update Submitted: 2019-12-11
• Study First Posted: 2019-12-13
• Last Update Posted: 2019-12-13
• Study Start: 2020-02
• Primary Completion: 2021-09
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
stereotactic body radiotherapy (SBRT)	stereotactic body radiotherapy (SBRT)	Noninvasive SBRT will be delivered in a single fraction to bilateral renal arteries determined by CT-guidance.

Primary Outcome Measures

Name	Time	Method
Ambulatory Blood Pressure Reduction	90 days	Mean reduction in average 24-hour ambulatory blood pressure at 90 days post-treatment
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.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Xinhua Hospital, School of Medicine, Shanghai Jiao Tong University; 🇨🇳 Shanghai, Shanghai, China