Renal Sympathetic Modification in Patients With Essential Hypertension

Not Applicable

• Conditions: Essential Hypertension
• Interventions: Procedure: renal sympathetic modification

• Registration Number: NCT01417221
• Lead Sponsor: The Second Affiliated Hospital of Chongqing Medical University

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.

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-15
• Study First Submitted QC: 2011-08-15
• Study First Posted: 2011-08-16
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-18
• Last Update Posted: 2019-03-19
• Primary Completion: 2019-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
renal sympathetic modification	renal sympathetic modification	Renal artery ablation to modify sympathetic activity in patients with essential hypertension.

Primary Outcome Measures

Name	Time	Method
composite cardiovascular events	three years	Comprising myocardial infarction, stroke, heart failure, sudden death

Trial Locations

Locations (1)

2ndChongqingMU; 🇨🇳 Chongqing, Chongqing, China