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To evaluate the efficacy and safety of selected renal sympathetic denervation using SyMapCath Iâ„¢ Catheter and SYMPIONEER S1â„¢ Stimulator/Generator in patients with hypertension in the absence of antihypertensive medications, or till the negative result was given by urinary antihypertensive drugs detection of high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) after at least two weeks of drug elution period.
Then Office systolic blood pressure (SBP) is still ≥ 150mmHg, < 180mmHg, diastolic blood pressure (DBP) ≥ 90mmHg, and 24-hour mean SBP of ambulatory blood pressure measurement (ABPM) is ≥130mmHg, or day-time mean SBP ≥135mmHg, or night-time mean SBP ≥120mmHg, and all SBP of ABMP record <170mmHg.
After then the patient will be included when the results of bilateral renal angiography meet the requirements of renal nerve stimulation, mapping and denervation conditions.
This is a prospective, multicenter, blind, randomized and controlled trial, in which patients are of essential hypertension, but in the absence of antihypertensive medications. The patients will be informed, consent and get into a screening process. After at least two weeks of drug elution period HPLC-MS/MS urinary antihypertensive drugs detection will be given till the negative result, or one extra week of drug elution period will be given for the second urinary drugs analysis. Then Office systolic blood pressure (SBP) is still ≥ 150mmHg, < 180mmHg, diastolic blood pressure (DBP) ≥ 90mmHg, and 24-hour mean SBP of ambulatory blood pressure measurement (ABPM) is ≥130mmHg, or day-time mean SBP ≥135mmHg, or night-time mean SBP ≥120mmHg, and all SBP of ABMP record <170mmHg.
These patients will conduct renal angiography, and the meet inclusion criteria individuals will be allocated to either renal nerve stimulation, mapping and denervation group (RDN group) or renal artery angiography group (Sham group) by a randomizing system in a 1:1 ratio (80 patients, 40 pairs). Physicians who perform post-procedure patient management and physicians who perform renal denervation procedures are blinded to each other.
Patients will be followed at the 2nd day, the 7th day after the procedure or at discharge from hospital, 1st month, 2nd month, 3rd month. Urine 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 Data Safety and Monitoring Board/Clinical Events Committee (DSMB/CEC) are formed and responsible for assessments of protocol deviations and natures of serious adverse events (SAEs).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RDN Group | Experimental | renal nerve stimulation, mapping and denervation using the SyMapCath Iâ„¢ Catheter and SYMPIONEER S1â„¢ Stimulator/Generator after renal angiography. |
|
| Sham Group | Sham Comparator | renal artery angiography group, without any renal nerve stimulation, mapping or denervation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Renal nerve stimulation, mapping and denervation | Procedure | After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal nerve stimulation, mapping and denervation procedure after randomization. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in office systolic blood pressure | 3 months after the treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in average 24-hour Ambulatory Blood Pressure Monitoring (ABPM) systolic blood pressure (SBP) | 3 months | |
| Change in average day-time ABPM SBP | 3 months | |
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Inclusion Criteria:
Exclusion Criteria:
1. Renal artery anatomy is unqualified including:
6. Participated other clinical trials including both drug and medical device studies within 3 months enrollment 7. Female with pregnant or lactating, or having plans for pregnancy within 1 year 8. Patient with sleep apnea who needs chronic oxygen-breathing or mechanical ventilation support (for example, tracheostomy) 9. Patients previously or currently suffering from following diseases:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuehui Yin, MD | Contact | 0086-13508335502 | yinyh63@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 2ndChongqingMU | Chongqing | Chongqing Municipality | 400010 | China |
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| Sham Procedure: Renal angiography | Procedure | After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal |
|
| Change in average night-time ABPM SBP |
| 3 months |
| Change in office diastolic blood pressure (DBP) | 3 months |
| Change in mean arterial blood pressure | 3 months |
| Change in the blood catecholamines levels of pre-procedure and 3 months after the procedure | 3 months |
| Rate of renal artery stenosis assessed by CT angiography | (stenosis > 70% ) | 3 months |
| Rate of severe renal dysfunction | eGFR<15ml/min/m2 or renal function replacement therapy needed | 3 months |
| Rate of adverse events (AEs), SAEs, and severe cardio-cerebrovascular events | 3 months |
| Rate of all-cause death | 3 months |
| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D006973 | Hypertension |
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| ID | Term |
|---|---|
| D003714 | Denervation |
| ID | Term |
|---|---|
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
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