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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
The Second People's Hospital of Chengdu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    July 6, 2011
    Last Updated
    July 8, 2011
    Sponsor
    The Second People's Hospital of Chengdu
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    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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