Hypertension Clinical Trial
Official title:
Renal Denervation Using Stereotactic Radiotherapy System for the Treatment of Refractory Hypertension
This study is conducted to investigate the short-term safety and preliminary efficacy of stereotactic radiotherapy for renal denervation to treat refractory hypertension.
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.
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