Renal Sympathetic Modification in Patients With Essential Hypertension

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by The Second Affiliated Hospital of Chongqing Medical University
Sponsor:
Collaborators:
Jiangsu Provincial People's Hospital
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

August 15, 2011
May 2, 2013
August 2011
December 2015   (final data collection date for primary outcome measure)
composite cardiovascular events [ Time Frame: three years ] [ Designated as safety issue: Yes ]
Comprising myocardial infarction, stroke, heart failure, sudden death
Same as current
Complete list of historical versions of study NCT01417221 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Renal Sympathetic Modification in Patients With Essential Hypertension
Renal Sympathetic Modification in Patients With Essential Hypertension

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Essential Hypertension
Procedure: renal sympathetic modification
Device: THERMOCOOL® Catheter Renal sympathetic modification with a catheter-based procedure
Other Name: renal denervation
  • Experimental: renal sympathetic modification
    Renal artery ablation to modify sympathetic activity in patients with essential hypertension.
    Intervention: Procedure: renal sympathetic modification
  • No Intervention: Absolute medicine therapy
    Maintenance of anti-hypertensive medications only
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
August 2016
December 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact: Yuehui Yin, MD 0086-13508335502 yinyh63@163.com
China
 
NCT01417221
SWAN-HT
Yes
Yuehui Yin, The Second Affiliated Hospital of Chongqing Medical University
The Second Affiliated Hospital of Chongqing Medical University
  • Jiangsu Provincial People's Hospital
  • Zunyi Medical College
  • Chongqing Medical University
Not Provided
The Second Affiliated Hospital of Chongqing Medical University
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP