Renal Sympathetic Modification in Patients With Essential Hypertension

The recruitment status of this study is unknown because the information has not been verified recently.

Verified May 2013 by The Second Affiliated Hospital of Chongqing Medical University.
Recruitment status was Recruiting

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

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

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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Zunyi Medical College

Chongqing Medical University

More Information


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 September 27, 2016

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