Hypertension
Conditions
Brief summary
The purpose of this study is to determine whether renal denervation is safe and effective in the treatment of Chinese patients with uncontrolled hypertension.
Detailed 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.
Interventions
DEVICETHERMOCOOL® Catheter
Catheter-based renal denervation
Sponsors
The Second People's Hospital of Chengdu
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure Reduction | one year | To confirm that renal denervation is safe, feasible and effective. |
Contacts
Primary ContactJian Xiong Liu, MD
Outcome results
None listed