- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03758196
Renal Sympathetic Denervation From the Adventitia on Resistant Hypertension(RSDARH)
Efficacy and Safety of Renal Sympathetic Denervation From the Adventitia on Resistant Hypertension.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yahui Liu, Bachelor
- Phone Number: +86 18317898825
- Email: 1182600873@qq.com
Study Contact Backup
- Name: Chuanyu Gao, Dr.
- Phone Number: +86 13937165590
- Email: gaocy6802@163.com
Study Locations
-
-
Henan
-
Zhengzhou, Henan, China
- Recruiting
- Zhengzhou university People's Hospital
-
Contact:
- Chuanyu Gao, Dr
- Phone Number: +86 13937165590
- Email: gaocy6802@163.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Renal sympathetic denervation from the adventitia
Renal sympathetic denervation from the adventitia of renal artery and optimized medication regimen
|
Renal Sympathetic Denervation from the adventitia of renal artery
|
No Intervention: optimized medication regimen
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in 24-hour average systolic blood pressure by ABPM in 6 months after discharge .
Time Frame: Baseline to 6 months
|
Baseline to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
Baseline to 6 months,12 months
|
Collaborators and Investigators
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HenanICE201802
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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