Renal Sympathetic Modification in Patients With Essential Hypertension

March 18, 2019 updated by: Yuehui Yin, The Second Affiliated Hospital of Chongqing Medical University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400010
        • Recruiting
        • 2ndChongqingMU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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
  • isolated systolic 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • renal denervation
No Intervention: Absolute medicine therapy
Maintenance of anti-hypertensive medications only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
composite cardiovascular events
Time Frame: three years
Comprising myocardial infarction, stroke, heart failure, sudden death
three years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Second Affiliated Hospital of Chongqing Medical University

Collaborators

Chongqing Medical University
Jiangsu Provincial People's Hospital
Zunyi Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2011

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

August 15, 2011

First Submitted That Met QC Criteria

August 15, 2011

First Posted (Estimate)

August 16, 2011

Study Record Updates

Last Update Posted (Actual)

March 19, 2019

Last Update Submitted That Met QC Criteria

March 18, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SWAN-HT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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