Renal Denervation in Patients With Uncontrolled Hypertension in Chinese
Primary Purpose
Hypertension
Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
THERMOCOOL® Catheter
Sponsored by

About this trial
This is an interventional treatment trial for Hypertension
Eligibility Criteria
Inclusion Criteria:
- >= 18 years of age
- a systolic blood pressure of 160mmHg or more and/or a diastolic blood pressure of 90mmHg or more
- receiving and adhering to at least three full doses of appropriate antihypertensive drug regimen
- estimated glomerular filtration rate (eGFR) of ≥45mL/min
- agrees to have the study procedure(s) performed and additional procedures and evaluations
- is competent and willing to provide written, informed consent to participate in this clinical study
Exclusion Criteria:
- secondary hypertension
- renal arterial abnormalities
- has experienced MI, unstable angina pectoris, or CVA within 6 months
- has an implantable cardioverter defibrillator (ICD) or pacemaker, or any other metallic implant which is not compatible with magnetic resonance imaging (MRI)
- requires respiratory support
- patients with sick sinus syndrome
- pregnant woman
- others
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Catheter, Renal Denervation, Ablation
anti-hypertensive medications
Arm Description
Catheter-based renal denervation and maintenance of anti-hypertensive medications
Maintenance of anti-hypertensive medications
Outcomes
Primary Outcome Measures
Blood Pressure Reduction
To confirm that renal denervation is safe, feasible and effective.
Secondary Outcome Measures
Full Information
NCT ID
NCT01390831
First Posted
July 6, 2011
Last Updated
July 8, 2011
Sponsor
The Second People's Hospital of Chengdu
1. Study Identification
Unique Protocol Identification Number
NCT01390831
Brief Title
Renal Denervation in Patients With Uncontrolled Hypertension in Chinese
Official Title
Renal Denervation in Patients With Uncontrolled Hypertension in Chinese
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Unknown status
Study Start Date
November 2011 (undefined)
Primary Completion Date
November 2014 (Anticipated)
Study Completion Date
June 2015 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
The Second People's Hospital of Chengdu
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine whether renal denervation is safe and effective in the treatment of Chinese patients with uncontrolled hypertension.
Detailed Description
Prevalence of hypertension is increasing in China.While actually,the controlled rate of hypertension is relatively low,though numerous safe and effective pharmacological therapies are used in clinical practice.Studies confirmed that renal sympathetic nerves contributed to development and perpetuation of hypertension. Previous study has stated that renal denervation was effective and safe in patients with resistant hypertension, while little data is known in Chinese patients. We hypothesis that renal denervation is effective and safe in treatment of Chinese patients with uncontrolled hypertension. This trial plan to recruit 100 patients(Ablation group VS Control group = 1:1) with a follow up duration of 3 years.Patients in ablation group will receive percutaneous renal denervation combined with necessary antihypertension drugs and patients in control group will receive appropriate antihypertension drugs. We aim to explore the long term safety and validity of renal denervation in Chinese patients with uncontrolled hypertension.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Catheter, Renal Denervation, Ablation
Arm Type
Experimental
Arm Description
Catheter-based renal denervation and maintenance of anti-hypertensive medications
Arm Title
anti-hypertensive medications
Arm Type
No Intervention
Arm Description
Maintenance of anti-hypertensive medications
Intervention Type
Device
Intervention Name(s)
THERMOCOOL® Catheter
Intervention Description
Catheter-based renal denervation
Primary Outcome Measure Information:
Title
Blood Pressure Reduction
Description
To confirm that renal denervation is safe, feasible and effective.
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
>= 18 years of age
a systolic blood pressure of 160mmHg or more and/or a diastolic blood pressure of 90mmHg or more
receiving and adhering to at least three full doses of appropriate antihypertensive drug regimen
estimated glomerular filtration rate (eGFR) of ≥45mL/min
agrees to have the study procedure(s) performed and additional procedures and evaluations
is competent and willing to provide written, informed consent to participate in this clinical study
Exclusion Criteria:
secondary hypertension
renal arterial abnormalities
has experienced MI, unstable angina pectoris, or CVA within 6 months
has an implantable cardioverter defibrillator (ICD) or pacemaker, or any other metallic implant which is not compatible with magnetic resonance imaging (MRI)
requires respiratory support
patients with sick sinus syndrome
pregnant woman
others
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jian Xiong Liu, MD
Phone
862886621522-5205
Email
steven.ljx@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jian Xiong Liu
Organizational Affiliation
The Second People's Hospital of Chengdu
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Renal Denervation in Patients With Uncontrolled Hypertension in Chinese
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