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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01390831 |
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Date of registration:
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06/07/2011 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Renal Denervation in Patients With Uncontrolled Hypertension in Chinese
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Scientific title:
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Renal Denervation in Patients With Uncontrolled Hypertension in Chinese |
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Date of first enrolment:
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November 2011 |
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Target sample size:
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100 |
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Recruitment status: |
Not yet recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01390831 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 1/Phase 2
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Contacts
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Name:
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Jian Xiong Liu, MD |
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Address:
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Telephone:
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862886621522-5205 |
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Email:
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steven.ljx@163.com |
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Affiliation:
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Name:
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Jian Xiong Liu |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Second People's Hospital of Chengdu |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hypertension
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Intervention(s)
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Device: THERMOCOOL® Catheter
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Primary Outcome(s)
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Blood Pressure Reduction
[Time Frame: one year]
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Secondary ID(s)
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2011SZ0118
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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