Renal Sympathetic Modification in Patients With Essential Hypertension
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ClinicalTrials.gov Identifier: NCT01417221 |
Recruitment Status :
Recruiting
First Posted : August 16, 2011
Last Update Posted : March 19, 2019
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Condition or disease | Intervention/treatment | Phase |
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Essential Hypertension | Procedure: renal sympathetic modification | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 200 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Renal Sympathetic Modification in Patients With Essential Hypertension |
Actual Study Start Date : | August 2011 |
Estimated Primary Completion Date : | December 2019 |
Estimated Study Completion Date : | December 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: renal sympathetic modification
Renal artery ablation to modify sympathetic activity in patients with essential hypertension.
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Procedure: renal sympathetic modification
Device: THERMOCOOL® Catheter Renal sympathetic modification with a catheter-based procedure
Other Name: renal denervation |
No Intervention: Absolute medicine therapy
Maintenance of anti-hypertensive medications only
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- composite cardiovascular events [ Time Frame: three years ]Comprising myocardial infarction, stroke, heart failure, sudden death

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- ≥ 18 years old, and ≤ 75 years old of age
- more than half a year history of hypertension, except for valvular heart disease
- recently at least three times office blood pressure suggest systolic blood pressure of 140mmHg or more and/or a diastolic blood pressure of 90mmHg or more
- estimated glomerular filtration rate (eGFR) of ≥ 45mL/min
- is competent and willing to provide written, informed consent to participate in this clinical study
Exclusion Criteria:
- secondary hypertension
- isolated systolic hypertension
- estimated glomerular filtration rate (eGFR) of < 45mL/min
- has the history of renal restenosis or renal stents implantation
- has experienced AMI (old myocardial infarction is not excluded), unstable angina pectoris, cerebrovascular accidents, and alimentary tract hemorrhage within 3 months
- patients with sick sinus syndrome
- pregnant women
- mental disorders
- patients that have allergy to contrast agent
- patients that do not go with follow-up
- others such as researcher considers it is not appropriate to be included into the study

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01417221
Contact: Yuehui Yin, MD | 0086-13508335502 | yinyh63@163.com |
China, Chongqing | |
2ndChongqingMU | Recruiting |
Chongqing, Chongqing, China, 400010 | |
Contact: Yuehui Yin, MD 0086-23-63693766 yinyh63@163.com | |
Principal Investigator: Yuehui Yin, MD |
Responsible Party: | Yuehui Yin, Director and Professor, Dept. of Cardiology, the second affiliated hospital of Chongqing Medical University, Chongqing Cardiac arrhythmias service center, The Second Affiliated Hospital of Chongqing Medical University |
ClinicalTrials.gov Identifier: | NCT01417221 |
Other Study ID Numbers: |
SWAN-HT |
First Posted: | August 16, 2011 Key Record Dates |
Last Update Posted: | March 19, 2019 |
Last Verified: | March 2019 |
renal artery sympathetic nerves modification essential hypertension primary hypertension |
Hypertension Essential Hypertension Vascular Diseases Cardiovascular Diseases |