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Renal Sympathetic Modification in Patients With Essential Hypertension

Primary Purpose

Essential Hypertension

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
renal sympathetic modification
Sponsored by
The Second Affiliated Hospital of Chongqing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Hypertension focused on measuring renal artery, sympathetic nerves, modification, essential hypertension, primary hypertension

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 2ndChongqingMURecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

renal sympathetic modification

Absolute medicine therapy

Arm Description

Renal artery ablation to modify sympathetic activity in patients with essential hypertension.

Maintenance of anti-hypertensive medications only

Outcomes

Primary Outcome Measures

composite cardiovascular events
Comprising myocardial infarction, stroke, heart failure, sudden death

Secondary Outcome Measures

Full Information

First Posted
August 15, 2011
Last Updated
March 18, 2019
Sponsor
The Second Affiliated Hospital of Chongqing Medical University
Collaborators
Jiangsu Provincial People's Hospital, Zunyi Medical College, Chongqing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01417221
Brief Title
Renal Sympathetic Modification in Patients With Essential Hypertension
Official Title
Renal Sympathetic Modification in Patients With Essential Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Second Affiliated Hospital of Chongqing Medical University
Collaborators
Jiangsu Provincial People's Hospital, Zunyi Medical College, Chongqing Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension
Keywords
renal artery, sympathetic nerves, modification, essential hypertension, primary hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
renal sympathetic modification
Arm Type
Experimental
Arm Description
Renal artery ablation to modify sympathetic activity in patients with essential hypertension.
Arm Title
Absolute medicine therapy
Arm Type
No Intervention
Arm Description
Maintenance of anti-hypertensive medications only
Intervention Type
Procedure
Intervention Name(s)
renal sympathetic modification
Other Intervention Name(s)
renal denervation
Intervention Description
Device: THERMOCOOL® Catheter Renal sympathetic modification with a catheter-based procedure
Primary Outcome Measure Information:
Title
composite cardiovascular events
Description
Comprising myocardial infarction, stroke, heart failure, sudden death
Time Frame
three years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuehui Yin, MD
Phone
0086-13508335502
Email
yinyh63@163.com
Facility Information:
Facility Name
2ndChongqingMU
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400010
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuehui Yin, MD
Phone
0086-23-63693766
Email
yinyh63@163.com
First Name & Middle Initial & Last Name & Degree
Yuehui Yin, MD

12. IPD Sharing Statement

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Renal Sympathetic Modification in Patients With Essential Hypertension

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