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Hypertension represents a significant global public health problem, contributing to vascular and renal morbidity, cardiovascular mortality, and economic burden. For a mostly asymptomatic disease, there is a huge challenge to maintain a good adherence and longtime persistence of drug use so as to adequately control it. Even so, a significant proportion of patients will develop resistant hypertension. In recent years, renal denervation has been argued as an effective means to address blood pressure problem in several non-Chinese clinical trials. The technique is to deliver low level radiofrequency energy through the renal artery wall to target the sympathetic nervous system and then modulate blood pressure.
Shanghai WiseGain Medical Devices Co., LTD has developed the WiseGo Catheter System, which is an irrigated radiofrequency ablation Catheter. With this Catheter, it is expected to improve blood pressure status among patients with resistant hypertension failing polypharmacy. The purpose of this randomized control trial is to obtain an assessment of the efficacy and safety of WiseGo renal denervation technique in the presence of three standard antihypertensive medications in Chinese patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renal Denervation plus Medications | Experimental | Renal denervation procedure after randomization plus maintenance of baseline standardised triple anti-hypertensive medications for 90 days and then medically necessary adjustment of antihypertensive medications for another 90 days |
|
| Medications | Active Comparator | Maintenance of baseline standardised triple antihypertensive medications after randomization for 90 days and then medically necessary adjustment of antihypertensive medications for another 90 days, after which, subjects will be allowed to cross over to perform renal denervation if they still meet the inclusion criteria for the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrequency ablation catheter | Device | Subjects will be treated with the renal denervation procedure using WiseGo Catheter System after randomization. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in average 24-hour systolic blood pressure by ambulatory blood pressure monitoring from baseline | 3 months post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of achieving target blood pressure | Target blood pressure is defined as daytime ambulatory blood pressure <135/85mmHg, nighttime ambulatory blood pressure <120/70mmHg or average 24-hour ambulatory blood pressure <130/80mmHg, respectively | 6 months post-randomization |
| Change in daytime and nighttime ambulatory systolic blood pressure from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 24 hour average, daytime and nighttime ambulatory systolic/diastolic blood pressure from baseline | 6 months post-randomization | |
| Change in office systolic/diastolic blood pressure from baseline | 6 months post-randomization |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Helen Chen, Dr. | Contact | 86-21-61400976 | helen6_2@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Junbo Ge, Dr. | Zhongshan Hospital affiliated to Fu Dan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Xiangya Hospital of Central South University | Changsha | Hunan | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24678939 | Background | Bhatt DL, Kandzari DE, O'Neill WW, D'Agostino R, Flack JM, Katzen BT, Leon MB, Liu M, Mauri L, Negoita M, Cohen SA, Oparil S, Rocha-Singh K, Townsend RR, Bakris GL; SYMPLICITY HTN-3 Investigators. A controlled trial of renal denervation for resistant hypertension. N Engl J Med. 2014 Apr 10;370(15):1393-401. doi: 10.1056/NEJMoa1402670. Epub 2014 Mar 29. | |
| 28864691 |
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| Amlodipine, losartan potassium and hydrochlorothiazide | Drug | Standardised triple anti-hypertensive medications of amlodipine 5 mg per day, losartan potassium 50 mg and hydrochlorothiazide 12.5 mg per day in the first 90 days after randomization. Subjects will be allowed to adjust baseline antihypertensive medications where clinically necessary in the second 90 days after randomization. |
|
| 3 months post-randomization |
| Change in 24 hour average, daytime and nighttime ambulatory diastolic blood pressure from baseline | 3 months post-randomization |
| Change in serum creatinine from baseline | 6 months post-randomization |
| Incidence of adverse event | Through study completion, up to 6 months |
| Change in patient-recorded home systolic/diastolic blood pressure from baseline | 6 months post-randomization |
| Incidences of achieving reductions of ≥ 5 mmHg, ≥ 10 mmHg, ≥15 mmHg, and ≥ 20 mmHg in blood pressure, including ambulatory, office and home blood pressure | 6 months post-randomization |
| Incidences of substantially adjusting antihypertensive medications | A substantial adjustment of antihypertensive medications is defined as any changes in number of antihypertensive medications, or type of antihypertensive medications, or ≥ 50% dose change in any ongoing antihypertensive medications in the last two weeks. | 6 months post-randomization |
| Zhongshan Hospital affiliated to Fu Dan University | Shanghai | Shanghai Municipality | 200032 | China |
|
| Changhai Hospital affiliated to Second Military Medical University | Shanghai | Shanghai Municipality | China |
|
| Putuo Hospital affiliated to Shanghai Traditional Chinese Medicine University | Shanghai | Shanghai Municipality | China |
|
| Shanghai Chest Hospital affiliated to Shanghai Jiao Tong University | Shanghai | Shanghai Municipality | China |
|
| Shanghai Ninth People's Hospital affiliated to Shanghai Jiao Tong University | Shanghai | Shanghai Municipality | China |
|
| Shanghai Sixth People's Hospital affiliated to Shanghai Jiao Tong University | Shanghai | Shanghai Municipality | China |
|
| Tongji Hospital affiliated to Tongji University | Shanghai | Shanghai Municipality | China |
|
| Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine Chongming Branch | Shanghai | Shanghai Municipality | China |
|
| Sir Run Run Shaw Hospital affiliated to Zhejiang University | Hangzhou | Zhejiang | China |
|
| The Second Hospital affiliated to Zhejiang University | Hangzhou | Zhejiang | China |
|
| Taizhou Hospital | Taizhou | Zhejiang | China |
|
| The First Hospital affiliated to Wenzhou Medical College | Wenzhou | Zhejiang | China |
|
| Liu Z, Shen L, Huang W, Zhao X, Fang W, Wang C, Yin Z, Wang J, Fu G, Liu X, Jiang J, Zhang Z, Li J, Lu Y, Ge J. Efficacy and safety of renal denervation for Chinese patients with resistant hypertension using a microirrigated catheter: study design and protocol for a prospective multicentre randomised controlled trial. BMJ Open. 2017 Sep 1;7(9):e015672. doi: 10.1136/bmjopen-2016-015672. |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D017115 | Catheter Ablation |
| D017311 | Amlodipine |
| D019808 | Losartan |
| D006852 | Hydrochlorothiazide |
| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D013777 | Tetrazoles |
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D049971 | Thiazides |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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