Renal Sympathetic Modification in Patients With Essential Hypertension

Essential Hypertension Clinical Trial

Official title:

Renal Sympathetic Modification in Patients With Essential Hypertension

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01417221
• Other study ID #: SWAN-HT
• Status: Recruiting
• Phase: N/A
• Start date: August 2011
• Est. completion date: December 2020

Study information

• Verified date: March 2019
• Source: The Second Affiliated Hospital of Chongqing Medical University
• Contact: Yuehui Yin, MD
• Phone: 0086-13508335502
• Email: yinyh63[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

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

Locations

Country	Name	City	State
China	2ndChongqingMU	Chongqing	Chongqing

Sponsors (4)

Lead Sponsor	Collaborator
The Second Affiliated Hospital of Chongqing Medical University	Chongqing Medical University, Jiangsu Provincial People's Hospital, Zunyi Medical College

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	composite cardiovascular events	Comprising myocardial infarction, stroke, heart failure, sudden death	three years