This is a prospective, multicenter, randomized sham-controlled trial to evaluate safety and efficacy of a multi-electrode radiofrequency renal denervation system (Netrod® System) in treating patients with uncontrolled essential hypertension.
This is a prospective, multicenter, randomized sham-controlled trial. Patients with uncontrolled hypertension (office BP ≥150/90 and \<180/110mmHg, and average SBP ≥135mmHg by 24-hour ambulatory BP monitoring (ABPM), after taking ≥2 antihypertensive drugs with stable dose for ≥ 4 weeks) were screened after informed consent. All eligible patients first entered a lead-in period for ≥4 weeks of standardized medication (Nifedipine + hydrochlorothiazide), and those continued to meet definition of uncontrolled hypertension were randomized 2:1 to RDN group and sham control group (renal artery angiography only). All continued with the 2-drug regimen and were evaluated at 7, 30, 60, 90 and 180 days post procedure. Both patients and site investigators who evaluate the patients were blinded to treatment assignment. The primary endpoint is office SBP change from baseline at 6 months post procedure. Secondary endpoints include changes from baseline of office DBP. 24-hour ABPM at 6 months post procedure and safety events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
205
A renal denervation system with a mesh 6-electrode radiofrequency ablation catheter and multi-channel radiofrequency generator
Calcium channel blocker, Diuretic
Catheterization without renal denervation
Beijing Anzhen Hospital, Capital Medical University
Office SBP change from baseline at 6 months post procedure
Change in office blood systolic pressure (SBP) at 6 months post procedure
Time frame: From baseline to 6 months
Office DBP change from baseline at 6 months post procedure
Change in office blood diastolic pressure (DBP) at 6 months post procedure
Time frame: From baseline to 6 months
Changes in 24-hour ambulatory BP at 6 months post procedure
Changes in 24-hour ambulatory SBP and DBP from baseline at 6 months post procedure measured by 24-hour ABPM
Time frame: From baseline to 6 months
Incidence of achieving target office SBP (90mmHg≤SBP<140mmHg) at 6 months post procedure
Patient proportion of achieving target office SBP (90mmHg≤SBP\<140mmHg) at 6 months post index procedure
Time frame: From baseline to 6 months
Proportion of office SBP decreased by ≥ 5mmHg at 6 months post index procedure
Proportion of office SBP decreased by ≥ 5mmHg at 6 months post index procedure
Time frame: From baseline to 6 months
The rate of major adverse events (MAE) through 6 months post index procedure
The rate of major adverse events (MAE) through 6 months post index procedure
Time frame: From index procedure to 6 months post procedure
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