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| Name | Class |
|---|---|
| Tigermed Consulting Co., Ltd | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renal Sympathetic Denervation | Experimental | Percutaneous renal denervation using the SyMapCath Iâ„¢ Catheter and SYMPIONEER S1â„¢ Stimulator/Generator. |
|
| Masked Procedure | Sham Comparator | Percutaneous renal artery angiography |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SyMapCath Iâ„¢ catheter and SYMPIONEER S1â„¢ Stimulator/Generator | Device | Radiofrequency ablation of renal arterial sympathetic nerves |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 6 months after the treatments |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in average 24-hour Ambulatory Blood Pressure Monitoring (ABPM) systolic blood pressure | 6 months | |
| Postoperative reduction in 24-hour ABPM in systolic, diastolic and mean arterial blood pressure | discharge day or 7 days after procedure |
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Inclusion Criteria:
Exclusion Criteria:
(1) essential pulmonary arterial hypertension, (2) type I diabetes, (3) patients with severe cardiac valvular stenosis who have contradictions and cannot rolerant to significantly reduce blood pressure, (4) within half year, patients had myocardial infraction, unstable angina, syncope or cerebrovascular accidents, (5) history of primary aldosteronism, pheochromocytoma, aorta stenosis, hyperthyroidism or hyperparathyreosis, (6) any disease conditions interfering the measurement of blood pressure (for instance, severe peripheral artery diseases, abdominal artery aneurysm, hemorrhagic disorders such as thrombocytopenia, hemophilia and severe anemia), (7) plans to have surgery or cardiovascular interventions within 6 months, (8) alcohol abuse or unknown drug dependence history, (9) neuroticisms such as depression or anxiety disorders, (10) non-compliant patients who are unable to follow the study protocol per physician's requests.
11. Any contradictions to conduct renal artery stimulation and ablation
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| Name | Affiliation | Role |
|---|---|---|
| Yong HUO, MD | Peking University First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Beijing | Beijing Municipality | 100038 | China | ||
| Peking University People's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38756107 | Derived | Wang J, Yin Y, Lu C, Lu Z, Hu J, Wang Y, Ge J, Jiang H, Yao C, Yan X, Ma W, Qi X, Dang Y, Chen S, Zhu J, Wang D, Ding C, Wang W, Liu J, Wang Y, Li H, Pan Z, Cui K, Li C, Liang X, Chen W, Sobotka PA, Zhang J, Esler M, Sun N, Chen M, Huo Y. Efficacy and safety of sympathetic mapping and ablation of renal nerves for the treatment of hypertension (SMART): 6-month follow-up of a randomised, controlled trial. EClinicalMedicine. 2024 May 7;72:102626. doi: 10.1016/j.eclinm.2024.102626. eCollection 2024 Jun. | |
| 36042146 |
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Our decision on whether to share the individual participant data depends on the opinions of the regulatory authorities in China, but so far the regulatory agencies have no clear instructions yet, thus we cannot make a decision at present.
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D011876 | Radionuclide Generators |
| ID | Term |
|---|---|
| D055618 | Radiation Equipment and Supplies |
| D004864 | Equipment and Supplies |
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| Reduction in office blood pressure | 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 | 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 | 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 | 7 days after the procedure or at the time the patient is discharged from hospital |
| All-cause death | 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 | 6 months, 24months, 36 months, 48 months and 60 months |
| Rate of renal artery stenosis assessed by CT angiography | (stenosis > 70% ) | 6 months, 24months, 36 months, 48 months and 60 months |
| AEs, SAEs, and severe cardio-cerebrovascular events | 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 | 24, 36, 48, 60 months |
| Beijing |
| Beijing Municipality |
| 100044 |
| China |
| The Second Afflicted Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | 400016 | China |
| Shenzhen People's Hospital | Shenzhen | Guangdong | 518020 | China |
| Norman Bethune International Peace Hospital | Shijiazhuang | Hebei | 050000 | China |
| Hebei General Hospital | Shijiazhuang | Hebei | 050057 | China |
| Daqing Oilfield General Hospital | Daqing | Heilongjiang | 163458 | China |
| Renmin Hospital of Wuhan University | Wuhan | Hubei | 430060 | China |
| Nanjing First Hospital | Nanjing | Jiangsu | 210000 | China |
| Jiangsu Province Hospital | Nanjing | Jiangsu | 210029 | China |
| The Affiliated Hospital of Xuzhou Medical University | Xuzhou | Jiangsu | 221004 | China |
| Shanghai Zhongshan Hospital, Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
| Taiyuan Central Hospital | Taiyuan | Shanxi | 030009 | China |
| West China Hospital, Sichuan University | Chengdu | Sichuan | 610041 | China |
| Tianjin First Center Hospital | Tianjin | Tianjin Municipality | 300192 | China |
| Derived |
| Wang J, Sun N, Ge J, Jiang H, Yin Y, Chen M, Wang Y, Yao C, Yan X, Sobotka PA, Huo Y. Rationale and Design of Sympathetic Mapping/Ablation of Renal Nerves Trial (SMART) for the Treatment of Hypertension: a Prospective, Multicenter, Single-Blind, Randomized and Sham Procedure-Controlled Study. J Cardiovasc Transl Res. 2023 Apr;16(2):358-370. doi: 10.1007/s12265-022-10307-z. Epub 2022 Aug 30. |
| 34269698 | Derived | Wang Y, Wang JW, Wang Y, Yang B, Yinghua Du A, Kong Z, Chen M, Wang J. Monitoring Antihypertensive Medication Adherence by Liquid Chromatography-Tandem Mass Spectrometry: Method Establishment and Clinical Application. J Cardiovasc Pharmacol. 2021 Oct 1;78(4):581-596. doi: 10.1097/FJC.0000000000001105. |