Renal Denervation in Patients With Uncontrolled Hypertension in Chinese

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2011 by The Second People's Hospital of Chengdu
Sponsor:
Information provided by:
The Second People's Hospital of Chengdu
ClinicalTrials.gov Identifier:
NCT01390831
First received: July 6, 2011
Last updated: July 8, 2011
Last verified: April 2011
  Purpose

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 Intervention Phase
Hypertension
Device: THERMOCOOL® Catheter
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Renal Denervation in Patients With Uncontrolled Hypertension in Chinese

Resource links provided by NLM:


Further study details as provided by The Second People's Hospital of Chengdu:

Primary Outcome Measures:
  • Blood Pressure Reduction [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    To confirm that renal denervation is safe, feasible and effective.


Estimated Enrollment: 100
Study Start Date: November 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Jian-xiong LIU, The Second People's Hospital of Chengdu
ClinicalTrials.gov Identifier: NCT01390831     History of Changes
Other Study ID Numbers: 2011SZ0118
Study First Received: July 6, 2011
Last Updated: July 8, 2011
Health Authority: United States: Food and Drug Administration
China: Ministry of Science and Technology
China: Ministry of Health

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 15, 2014