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Renal Sympathetic Modification in Patients With Essential Hypertension

This study is currently recruiting participants.
Verified May 2013 by The Second Affiliated Hospital of Chongqing Medical University
Sponsor:
Collaborators:
Jiangsu Provincial People's Hospital
Affiliated Hospital of Zunyi Medical College
Chongqing Medical University
Information provided by (Responsible Party):
Yuehui Yin, The Second Affiliated Hospital of Chongqing Medical University
ClinicalTrials.gov Identifier:
NCT01417221
First received: August 15, 2011
Last updated: May 2, 2013
Last verified: May 2013
History of Changes
  Purpose

The purpose of this study is to observe the incident of composite cardiovascular events after renal sympathetic modification using THERMOCOOL® catheter in patients with essential hypertension, and evaluate safety and efficacy of the intervention.


Condition Intervention
Essential Hypertension
 Procedure: renal sympathetic modification

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Renal Sympathetic Modification in Patients With Essential Hypertension

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Second Affiliated Hospital of Chongqing Medical University:

Primary Outcome Measures:
  • composite cardiovascular events [ Time Frame: three years ] [ Designated as safety issue: Yes ]
    Comprising myocardial infarction, stroke, heart failure, sudden death


Estimated Enrollment: 200
Study Start Date: August 2011
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: renal sympathetic modification
Renal artery ablation to modify sympathetic activity in patients with essential hypertension.
 Procedure: renal sympathetic modification
Device: THERMOCOOL® Catheter Renal sympathetic modification with a catheter-based procedure
Other Name: renal denervation
No Intervention: Absolute medicine therapy
Maintenance of anti-hypertensive medications only

Detailed Description:

Hypertension is a common cardiovascular disease, and is also an important risk factor for heart-brain-renal diseases, with relatively low controlled rate. Traditional pharmacological therapies are used in clinical practice without breakthrough for long time. Previous studies confirmed that sympathetic nerves activity contributed to development and perpetuation of hypertension. Renal ablation for sympathetic modification is a new method which is proved to be effective in decreasing sympathetic nerves activity. We assume that modifying renal sympathetic activity by ablation is effective and safe in treatment of hypertension. This trial is going to recruit 200 patients (Ablation group VS Control group = 1:1) with a follow-up duration of 3 years. Patients in ablation group will receive additional necessary anti-hypertensive medications besides expectant intervention, and patients in control group will receive appropriate anti-hypertensive medications only. We aim to observe the incident of composite cardiovascular events after renal sympathetic modification using THERMOCOOL® catheter in patients with hypertension, and evaluate safety and efficacy of the intervention.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥ 18 years old, and ≤ 75 years old of age
  • more than half a year history of hypertension, except for valvular heart disease
  • recently at least three times office blood pressure suggest systolic blood pressure of 140mmHg or more and/or a diastolic blood pressure of 90mmHg or more
  • estimated glomerular filtration rate (eGFR) of ≥ 45mL/min
  • is competent and willing to provide written, informed consent to participate in this clinical study

Exclusion Criteria:

  • secondary hypertension
  • estimated glomerular filtration rate (eGFR) of < 45mL/min
  • has the history of renal restenosis or renal stents implantation
  • has experienced AMI (old myocardial infarction is not excluded), unstable angina pectoris, cerebrovascular accidents, and alimentary tract hemorrhage within 3 months
  • patients with sick sinus syndrome
  • pregnant women
  • mental disorders
  • patients that have allergy to contrast agent
  • patients that do not go with follow-up
  • others such as researcher considers it is not appropriate to be included into the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01417221

Contacts
Contact: Yuehui Yin, MD 0086-13508335502 yinyh63@163.com

Locations
China, Chongqing
2ndChongqingMU Recruiting
Chongqing, Chongqing, China, 400010
Contact: Yuehui Yin, MD     0086-23-63693766     yinyh63@163.com    
Principal Investigator: Yuehui Yin, MD            
Sponsors and Collaborators
The Second Affiliated Hospital of Chongqing Medical University
Jiangsu Provincial People's Hospital
Affiliated Hospital of Zunyi Medical College
Chongqing Medical University
  More Information

No publications provided

Responsible Party: Yuehui Yin, Director and Professor, Dept. of Cardiology, the second affiliated hospital of Chongqing Medical University, Chongqing Cardiac arrhythmias service center, The Second Affiliated Hospital of Chongqing Medical University
ClinicalTrials.gov Identifier: NCT01417221     History of Changes
Other Study ID Numbers: SWAN-HT
Study First Received: August 15, 2011
Last Updated: May 2, 2013
Health Authority: China: Clinical Pharmacological Base of 2ndChongqingMU

Keywords provided by The Second Affiliated Hospital of Chongqing Medical University:
renal artery
sympathetic nerves
modification
essential hypertension
primary hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013