To evaluate the safety and efficacy of targeted renal sympathetic denervation using SyMapCath I™ in patients on hemodialysis with pharmacotherapy and uncontrolled hypertension for at least 6 months, then after standardized antihypertensive drug therapy (at least two drugs) for at least 28 days, office systolic blood pressure (BP) is still ≥ 150mmHg, ≤180mmHg.
This is a prospective, single-center, open-label, self controlled case series trial, in which patients on maintenance hemodialysis are diagnosed with essential hypertension with at least six months of 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 BP is still ≥ 150mmHg, ≤180mmHg, and meet the inclusion and exclusion criteria. These patients will conduct renal artery angiography followed by renal sympathetic nerve denvervation (30 patients). Patients with office BP which is not achieved ideal level (\<140 mmHg) will titrate doses of classes of antihypertensive drugs according to a predefined standardized medication regimen until their office BP \<140 mmHg. Patients will be followed at 7 days after the procedure or at discharge from hospital, 1 month, 3 months and 6 months. Blood samples will be collected for drug tests to determine drug compliance of a patient. Data collecting/management/statistical analysis and laboratory tests will be performed by independent, qualified organizations. Independent DSMB/CEC are formed and responsible for assessments of protocol deviations and natures of SAEs.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Radiofrequency ablation of renal arterial sympathetic nerves
Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
RECRUITINGReduction in office BP
Reduction in office BP at 3 month after the treatment
Time frame: 3 month after the treatment
The composite index of anti-hypertensive drugs
The composite index of anti-hypertensive drugs at 6 months after the treatments
Time frame: 6 months after the treatments
Reduction in office BP
Reduction in office BP at 1 month and 6 months after the treatment
Time frame: 1 month, 6 months
Postoperative reduction in 24-hour Ambulatory Blood Pressure Monitoring (ABPM) reduction in systolic, diastolic and mean arterial blood pressure
Time frame: 1 month, 3 months, 6 months
The control rates of reduction in office systolic blood pressure (SBP) by 10mmHg or Ambulatory Systolic Blood Pressure (ASBP) by 5mmHg
Time frame: 1 month, 3 months, 6 months
The control rates of office systolic blood pressure ( SBP<140mmHg)
The control rates of office systolic blood pressure ( SBP\<140mmHg) at 6 month after the treatment
Time frame: 6 month
Incidence of Intradialytic hypotension (IDH)
Decrease in systolic BP of ≥ 20 mm Hg during hemodialysis
Time frame: 1 month, 3 months, 6 months
All-cause death
Time frame: 1 month, 3 months, 6 months
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AEs, SAEs, and severe cardio-cerebrovascular events
Time frame: 1 month, 3 months, 6 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
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
Rate of renal artery stenosis assessed by CT angiography
stenosis \> 70%
Time frame: 6 months