Renal Denervation in Patients With Uncontrolled Hypertension in Chinese

The Second People's Hospital of Chengdu

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Hypertension

Treatments

Device: THERMOCOOL® Catheter

Study type

Interventional

Funder types

Other

Identifiers

NCT01390831

2011SZ0118

Details and patient eligibility

About

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

Full description

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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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