To evaluate the safety and efficacy of targeted renal sympathetic denervation using SyMapCath I® and SYMPIONEER S1® Stimulator/ Generator in patients with essential hypertension for at least 6 months of the disease history and pharmacotherapy, however, their blood pressure still cannot be controlled, then after standardized antihypertensive drug therapy (at least two drugs) for at least 28 days, office systolic blood pressure is still ≥ 150mmHg, ≤180mmHg.
This is a prospective, multicenter, single blind, randomized and sham controlled trial, in which patients are diagnosed with essential hypertension with at least six months of the disease history and pharmacotherapy however their blood pressure still cannot be controlled. The patients will be informed, consent and get into a screening process. During the screening period patients will receive a standardized antihypertensive drug treatment for at least 28 days and office systolic blood pressure is still ≥ 150mmHg, ≤180mmHg, and meet the inclusion and exclusion criteria. These patients will conduct renal artery angiography and be allocated to either renal sympathetic nerve denervation group or renal artery angiography group by a randomizing system in a 1:1 ratio (220 patients, 110 pairs). Patients with office systolic blood pressure which is not achieved ideal level (\<140 mmHg) will titrate doses or classes of antihypertensive drugs according to a predefined standardized medication regimen until their office systolic blood pressure \<140 mmHg, whereas in principle patients should follow the drug titration regimen, however, it is allowed to adjust antihypertensive medications per the real-world needs after 12 months. Physicians who perform post-procedure patient management and physicians who perform renal denervation procedures are blinded to each other. Patients will be followed at 7 days after the procedure or at discharge from hospital, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 9 months, 12months, 24months, 36 months, 48 months and 60 months for blood pressure measurements and antihypertensive medications. Urine samples will be collected for drug tests (LC-MS/MS) to determine drug compliance of a patient by an independent laboratory. Data collecting/management/statistical analysis and laboratory tests will be done by independent, qualified organizations. Independent DSMB/CEC are formed and responsible for assessments of protocol deviations and natures of SAEs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
220
Radiofrequency ablation of renal arterial sympathetic nerves
Peking University First Hospital
Beijing, Beijing Municipality, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
The control rate of office systolic blood pressure ( SBP<140mmHg)
The control rate of office systolic blood pressure ( SBP\<140mmHg) at 6 months after the treatment
Time frame: 6 months after the treatment
Change in the composite index of antihypertensive drugs to reach control of office systolic blood pressure (<140mmHg)
Change in the composite index of antihypertensive drugs to reach control of office systolic blood pressure (\<140mmHg) at 6 months after the treatment
Time frame: 6 months after the treatments
Reduction in average 24-hour Ambulatory Blood Pressure Monitoring (ABPM) systolic blood pressure
Time frame: 6 months
Postoperative reduction in 24-hour ABPM in systolic, diastolic and mean arterial blood pressure
Time frame: discharge day or 7 days after procedure
Reduction in office blood pressure
Time frame: 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 12 months, 24months, 36 months, 48 months and 60 months
Change in composite index of antihypertensive drugs
Time frame: 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 12 months, 24months, 36 months, 48 months and 60 months
Success rate of the renal interventional therapy procedure
the renal denervation catheter can be engaged to the correct position in renal artery, successfully performed renal nerve ablation procedure and has no related complications such as renal arterial perforation
Time frame: during the procedure
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The Second Afflicted Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Shenzhen People's Hospital
Shenzhen, Guangdong, China
Norman Bethune International Peace Hospital
Shijiazhuang, Hebei, China
Hebei General Hospital
Shijiazhuang, Hebei, China
Daqing Oilfield General Hospital
Daqing, Heilongjiang, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
Nanjing First Hospital
Nanjing, Jiangsu, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
...and 5 more locations
Success rate of clinical treatment
based on succeed performance of renal interventional therapy procedure , there are no the procedure-related SAE, such as acute infection and renal dysfunction
Time frame: 7 days after the procedure or at the time the patient is discharged from hospital
All-cause death
Time frame: 1 month, 3 months, 6 months, 9 months, 12 months, 24months, 36 months, 48 months and 60 months
Severe renal dysfunction
eGFR\<15mL/min/m2 or renal function replacement therapy needed
Time frame: 6 months, 24months, 36 months, 48 months and 60 months
Rate of renal artery stenosis assessed by CT angiography
(stenosis \> 70% )
Time frame: 6 months, 24months, 36 months, 48 months and 60 months
AEs, SAEs, and severe cardio-cerebrovascular events
Time frame: 1 month, 3 months, 6 months, 9 months, 12months, 24months, 36 months, 48 months and 60 months
Reduction in 24-hour ABPM in systolic and diastolic arterial blood pressure
Time frame: 24, 36, 48, 60 months