The purpose of ALLEGRO-HTN trial is to evaluate the safety and effectiveness of renal denervation in subjects with resistant hypertension by using Allegro renal denervation system
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Fuwai hospital
Beijing, China
Change in office-based systolic blood pressure (SBP) from baseline to 6 months
Time frame: 6 month
Change in average 24-hour SBP by ambulatory blood pressure monitoring (ABPM) from baseline to 6 months
Change in average 24-hour SBP by ambulatory blood pressure monitoring (ABPM) from baseline to 6 months
Time frame: 6 month
• The incidence of major adverse events (MAE) at 1 month postrandomization
Time frame: 1-month post randomization
Office SBP and DBP at 1, 3, 6 months postrandomization
Time frame: up to 6 months
• Patient-recorded home systolic blood pressure at 1, 3, 6 months postrandomization
Time frame: up to 6 months
• MAE at 6-month post-randomization, including new renal artery stenosis >60%
Time frame: up to 6 months
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