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As one of the most common chronic diseases,The adult prevalence of hypertension is approximately 26.4% at present and will rise to 29.2% by 2025.Renal sympathetic denervation from the intima of renal artery has emerged as a potential treatment for resistant hypertension. However, renal sympathetic nerve are mainly located in the adventitia,and there is no report on renal sympathetic denervation from the adventitia of renal artery.This study is a multicenter,randomized,single-blind study,and aimed to observe the safety and efficacy of radiofrequency ablation of the renal artery from the adventitia on the basis of laparoscopic techniques for patients with resistant hypertension.
This study is a multicenter,randomized,single-blind study,and aimed to observe the safety and efficacy of radiofrequency ablation of the renal artery from the adventitia on the basis of laparoscopic techniques for patients with resistant hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renal sympathetic denervation from the adventitia | Experimental | Renal sympathetic denervation from the adventitia of renal artery and optimized medication regimen |
|
| optimized medication regimen | No Intervention | optimized medication regimen |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrequency ablation instruments | Device | Renal Sympathetic Denervation from the adventitia of renal artery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in 24-hour average systolic blood pressure by ABPM in 6 months after discharge . | Baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in types and doses of antihypertensive medications in 1,3,6,12 months after discharge. | Baseline to 1 months,3 months,6 months,12 months | |
| Change in 24-hour average diastolic blood pressure,daytime and nighttime systolic/diastolic blood pressure by ABPM in 6 months after discharge |
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Inclusion Criteria:
1.18 years old ≤ age ≤ 65 years old; 2.Patients with clear diagnosis of resistant hypertension prior to enrollment:On the basis of improving lifestyle, a reasonable and tolerable amount of 3 or more kinds of antihypertensive drugs (including diuretics) for more than one month, clinic SBP≥140mmHg or (and) DBP≥90mmHg, 24 hours dynamic Blood pressure monitoring SBP>130mmHg or (and) DBP>80mmHg; 3.Estimated GFR (eGFR) ≥ 60ml/min/1.73m2; 4.The patient or his legal guardian has signed the informed consent; 5.Patients who are willing and able to perform follow-up visits.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yahui Liu, Bachelor | Contact | +86 18317898825 | 1182600873@qq.com | |
| Chuanyu Gao, Dr. | Contact | +86 13937165590 | gaocy6802@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Chuanyu Gao, Dr. | Henan Provincial People's Hospital | Principal Investigator |
| Jiguang Huang, Dr. | Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine;Shanghai Institute of Hypertension | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhengzhou university People's Hospital | Recruiting | Zhengzhou | Henan | China |
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| Baseline to 6 months |
| Change in 24-hour average blood pressure,daytime and nighttime systolic/diastolic blood pressure by ABPM in 1,3,12 months after discharge | Baseline to 1 months,3 months,12 months |
| Change in office systolic/diastolic blood pressure in 1,3,6,12 months after discharge | Baseline to 1 months,3 months,6 months,12 months |
| Change in systolic/diastolic blood pressure by home blood pressure monitoring in 1,3,6,12 months after discharge | Baseline to 1 months,3 months,6 months,12 months |
| renal function in 1,3,6,12 months after discharge | Baseline to 1 months,3 months,6 months,12 months |
| The surgical complications of renal artery perforation,such as stenosis,and dissection associated with radiofrequency surgery.And major cardiovascular and cerebrovascular events ,including cardiac death,stroke and nonfatal- myocardial infarction. | Baseline to 6 months,12 months |