Renal Sympathetic Modification in Patients With Essential Hypertension

NCT01417221 | Unknown DMC

• 1 other identifier: SWAN-HT
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Essential Hypertension

Keywords

renal artery; sympathetic nerves; modification; essential hypertension; primary hypertension

Outcome Measures

Primary Outcomes (1)

• composite cardiovascular events

  Comprising myocardial infarction, stroke, heart failure, sudden death

  three years

Study Arms (2)

renal sympathetic modification

EXPERIMENTAL

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

Procedure: renal sympathetic modification

Absolute medicine therapy

NO INTERVENTION

Maintenance of anti-hypertensive medications only

Interventions

renal sympathetic modification PROCEDURE

Device: THERMOCOOL® Catheter Renal sympathetic modification with a catheter-based procedure

Also known as: renal denervation

renal sympathetic modification

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Second Affiliated Hospital of Chongqing Medical University: lead
• Jiangsu Provincial People's Hospital: collaborator
• Zunyi Medical College: collaborator
• Chongqing Medical University: collaborator

Study Sites (1)

2ndChongqingMU

Chongqing, Chongqing Municipality, 400010, China

RECRUITING

MeSH Terms

Conditions

Essential Hypertension

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Yuehui Yin, MD

CONTACT

0086-13508335502; yinyh63@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director and Professor, Dept. of Cardiology, the second affiliated hospital of Chongqing Medical University, Chongqing Cardiac arrhythmias service center

Study Record Dates

• First Submitted: August 15, 2011
• First Posted: August 16, 2011
• Study Start: August 1, 2011
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2020
• Last Updated: March 19, 2019

Record last verified: 2019-03

Locations

CN (1)