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Renal Denervation in Patients With Uncontrolled Hypertension in Chinese

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ClinicalTrials.gov Identifier: NCT01390831
Recruitment Status : Unknown
Verified April 2011 by The Second People's Hospital of Chengdu.
Recruitment status was:  Not yet recruiting
First Posted : July 11, 2011
Last Update Posted : July 11, 2011
Sponsor:
Information provided by:
The Second People's Hospital of Chengdu

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.

Condition or disease Intervention/treatment Phase
Hypertension Device: THERMOCOOL® Catheter Phase 1 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Renal Denervation in Patients With Uncontrolled Hypertension in Chinese
Study Start Date : November 2011
Estimated Primary Completion Date : November 2014
Estimated Study Completion Date : June 2015

Arm Intervention/treatment
Experimental: Catheter, Renal Denervation, Ablation
Catheter-based renal denervation and maintenance of anti-hypertensive medications
Device: THERMOCOOL® Catheter
Catheter-based renal denervation
No Intervention: anti-hypertensive medications
Maintenance of anti-hypertensive medications



Primary Outcome Measures :
  1. Blood Pressure Reduction [ Time Frame: one year ]
    To confirm that renal denervation is safe, feasible and effective.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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): NCT01390831


Contacts
Contact: Jian Xiong Liu, MD 862886621522-5205 steven.ljx@163.com

Sponsors and Collaborators
The Second People's Hospital of Chengdu
Investigators
Principal Investigator: Jian Xiong Liu The Second People's Hospital of Chengdu

Responsible Party: Jian-xiong LIU, The Second People's Hospital of Chengdu
ClinicalTrials.gov Identifier: NCT01390831     History of Changes
Other Study ID Numbers: 2011SZ0118
First Posted: July 11, 2011    Key Record Dates
Last Update Posted: July 11, 2011
Last Verified: April 2011

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents