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出境医 / 临床实验 / Renal Sympathetic Denervation From the Adventitia on Resistant Hypertension（RSDARH）
Renal Sympathetic Denervation From the Adventitia on Resistant Hypertension（RSDARH）
Study Description
Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Resistant Hypertension | Device: Radiofrequency ablation instruments | Not Applicable |
Detailed Description:
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.
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 126 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Treatment |
| Official Title: | Efficacy and Safety of Renal Sympathetic Denervation From the Adventitia on Resistant Hypertension. |
| Actual Study Start Date : | October 31, 2018 |
| Estimated Primary Completion Date : | December 31, 2020 |
| Estimated Study Completion Date : | December 31, 2021 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Renal sympathetic denervation from the adventitia
Renal sympathetic denervation from the adventitia of renal artery and optimized medication regimen
|
Device: Radiofrequency ablation instruments
Renal Sympathetic Denervation from the adventitia of renal artery
|
|
No Intervention: optimized medication regimen
optimized medication regimen
|
Outcome Measures
Primary Outcome Measures :
- Change in 24-hour average systolic blood pressure by ABPM in 6 months after discharge . [ Time Frame: Baseline to 6 months ]
Secondary Outcome Measures :
- Change in types and doses of antihypertensive medications in 1,3,6,12 months after discharge. [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline to 1 months,3 months,12 months ]
- Change in office systolic/diastolic blood pressure in 1,3,6,12 months after discharge [ Time Frame: 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 [ Time Frame: Baseline to 1 months,3 months,6 months,12 months ]
- renal function in 1,3,6,12 months after discharge [ Time Frame: 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. [ Time Frame: Baseline to 6 months,12 months ]
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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:
- Patients with secondary hypertension caused by any known cause;
- pregnant or planning to be pregnant;
- Patients with renal artery diameter <4mm or length <20mm;
- Patients with renal artery abnormalities include: hemodynamic or anatomically significant stenosis (≥50%) of renal arteries on either side;renal arterial balloon angioplasty or stenting;renal involvement on either side Multiple renal arteries,and renal arteries supply <75% of the kidneys;abnormal renal artery anatomy,such as tumor expansion;
- Patients with cardiovascular instability factors includes:acute myocardial infarction within six months,unstable angina or cerebrovascular disease;heart valve disease with significantly altered hemodynamics;
- Patients with other serious organic diseases;
- Patients participated in other studies.
Contacts and Locations
Contacts
| Contact: Yahui Liu, Bachelor | +86 18317898825 | 1182600873@qq.com | |
| Contact: Chuanyu Gao, Dr. | +86 13937165590 | gaocy6802@163.com |
Locations
| China, Henan | |
| Zhengzhou university People's Hospital | Recruiting |
| Zhengzhou, Henan, China | |
| Contact: Chuanyu Gao, Dr +86 13937165590 gaocy6802@163.com | |
Sponsors and Collaborators
Henan Institute of Cardiovascular Epidemiology
Investigators
| Principal Investigator: | 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 |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | November 27, 2018 | ||||||||
| First Posted Date ICMJE | November 29, 2018 | ||||||||
| Last Update Posted Date | March 12, 2020 | ||||||||
| Actual Study Start Date ICMJE | October 31, 2018 | ||||||||
| Estimated Primary Completion Date | December 31, 2020 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Change in 24-hour average systolic blood pressure by ABPM in 6 months after discharge . [ Time Frame: Baseline to 6 months ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
|
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Renal Sympathetic Denervation From the Adventitia on Resistant Hypertension（RSDARH） | ||||||||
| Official Title ICMJE | Efficacy and Safety of Renal Sympathetic Denervation From the Adventitia on Resistant Hypertension. | ||||||||
| Brief Summary | 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. | ||||||||
| Detailed Description | 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. | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) Primary Purpose: Treatment |
||||||||
| Condition ICMJE | Resistant Hypertension | ||||||||
| Intervention ICMJE | Device: Radiofrequency ablation instruments
Renal Sympathetic Denervation from the adventitia of renal artery
|
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| Study Arms ICMJE |
|
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| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
126 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | December 31, 2021 | ||||||||
| Estimated Primary Completion Date | December 31, 2020 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
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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| Sex/Gender ICMJE |
|
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| Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
|
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| Listed Location Countries ICMJE | China | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03758196 | ||||||||
| Other Study ID Numbers ICMJE | HenanICE201802 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement ICMJE | Not Provided | ||||||||
| Responsible Party | Henan Institute of Cardiovascular Epidemiology | ||||||||
| Study Sponsor ICMJE | Henan Institute of Cardiovascular Epidemiology | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| PRS Account | Henan Institute of Cardiovascular Epidemiology | ||||||||
| Verification Date | March 2020 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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