Renal Denervation in Patients With Uncontrolled Hypertension in Chinese

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2015-06-30

Brief Summary

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The purpose of this study is to determine whether renal denervation is safe and effective in the treatment of Chinese patients with uncontrolled hypertension.

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Detailed Description

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Prevalence of hypertension is increasing in China.While actually,the controlled rate of hypertension is relatively low,though numerous safe and effective pharmacological therapies are used in clinical practice.Studies confirmed that renal sympathetic nerves contributed to development and perpetuation of hypertension. Previous study has stated that renal denervation was effective and safe in patients with resistant hypertension, while little data is known in Chinese patients. We hypothesis that renal denervation is effective and safe in treatment of Chinese patients with uncontrolled hypertension. This trial plan to recruit 100 patients(Ablation group VS Control group = 1:1) with a follow up duration of 3 years.Patients in ablation group will receive percutaneous renal denervation combined with necessary antihypertension drugs and patients in control group will receive appropriate antihypertension drugs. We aim to explore the long term safety and validity of renal denervation in Chinese patients with uncontrolled hypertension.

Conditions

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Hypertension

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Catheter, Renal Denervation, Ablation

Catheter-based renal denervation and maintenance of anti-hypertensive medications

Group Type EXPERIMENTAL

THERMOCOOL® Catheter

Intervention Type DEVICE

Catheter-based renal denervation

anti-hypertensive medications

Maintenance of anti-hypertensive medications

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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THERMOCOOL® Catheter

Catheter-based renal denervation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* \>= 18 years of age
* a systolic blood pressure of 160mmHg or more and/or a diastolic blood pressure of 90mmHg or more
* receiving and adhering to at least three full doses of appropriate antihypertensive drug regimen
* estimated glomerular filtration rate (eGFR) of ≥45mL/min
* agrees to have the study procedure(s) performed and additional procedures and evaluations
* is competent and willing to provide written, informed consent to participate in this clinical study

Exclusion Criteria

* secondary hypertension
* renal arterial abnormalities
* has experienced MI, unstable angina pectoris, or CVA within 6 months
* has an implantable cardioverter defibrillator (ICD) or pacemaker, or any other metallic implant which is not compatible with magnetic resonance imaging (MRI)
* requires respiratory support
* patients with sick sinus syndrome
* pregnant woman
* others

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No