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Renal Sympathetic Modification in Patients With Essential Hypertension

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ClinicalTrials.gov Identifier: NCT01417221
Recruitment Status : Recruiting
First Posted : August 16, 2011
Last Update Posted : March 19, 2019
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Essential Hypertension Procedure: renal sympathetic modification Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Renal Sympathetic Modification in Patients With Essential Hypertension
Actual Study Start Date : August 2011
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

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Arms and Interventions
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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 Name: renal denervation
No Intervention: Absolute medicine therapy
Maintenance of anti-hypertensive medications only


Outcome Measures
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Primary Outcome Measures :
  1. composite cardiovascular events [ Time Frame: three years ]
    Comprising myocardial infarction, stroke, heart failure, sudden death


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
  • 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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01417221


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

Locations
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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
Zunyi Medical College
Chongqing Medical University
More Information
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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
First Posted: August 16, 2011    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Keywords provided by Yuehui Yin, The Second Affiliated Hospital of Chongqing Medical University:
renal artery
sympathetic nerves
modification
essential hypertension
primary hypertension
Additional relevant MeSH terms:
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Hypertension
Essential Hypertension
Vascular Diseases
Cardiovascular Diseases