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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04198155
• Other study ID #: 19XHCR20D
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2020
• Est. completion date: December 2021

Study information

• Verified date: December 2019
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Yi-Gang Li, MD
• Phone: 86-13761318166
• Email: liyigang[@]xinhuamed.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is conducted to investigate the short-term safety and preliminary efficacy of stereotactic radiotherapy for renal denervation to treat refractory hypertension.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 18
• Est. completion date: December 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension

Intervention

Radiation:
• stereotactic body radiotherapy (SBRT)
Image-guided stereotactic body radiation therapy

Locations

Country	Name	City	State
China	Xinhua Hospital, School of Medicine, Shanghai Jiao Tong University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Ambulatory Blood Pressure Reduction	Mean reduction in average 24-hour ambulatory blood pressure at 90 days post-treatment	90 days
Secondary	Office Blood Pressure Reduction	Mean reduction in office blood pressure at 90 days post-treatment	90 days
Secondary	Number of Drug Adjustments	Number of drug adjustments for hypertension through 90 days after treatment	90 days