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

NCT ID: NCT04198155

Last Updated: 2019-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-29

Study Completion Date

2021-12-31

Brief Summary

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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

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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.

Conditions

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Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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stereotactic body radiotherapy (SBRT)

Noninvasive SBRT will be delivered in a single fraction to bilateral renal arteries determined by CT-guidance.

Group Type EXPERIMENTAL

stereotactic body radiotherapy (SBRT)

Intervention Type RADIATION

Image-guided stereotactic body radiation therapy

Interventions

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stereotactic body radiotherapy (SBRT)

Image-guided stereotactic body radiation therapy

Intervention Type RADIATION

Eligibility Criteria

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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.
Minimum Eligible Age

55 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yi-Gang Li, MD

Role: PRINCIPAL_INVESTIGATOR

Xinhua Hospital, School of Medicine, Shanghai Jiao Tong University

Locations

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Xinhua Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Central Contacts

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Yi-Gang Li, MD

Role: CONTACT

Phone: 86-13761318166

Email: [email protected]

Xingxing Cai, MD&PhD

Role: CONTACT

Phone: 86-18217730053

Email: [email protected]

Other Identifiers

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19XHCR20D

Identifier Type: -

Identifier Source: org_study_id