Renal Denervation in Patients With Uncontrolled Hypertension in Chinese

Hypertension Clinical Trial

Official title:

Renal Denervation in Patients With Uncontrolled Hypertension in Chinese

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01390831
• Other study ID #: 2011SZ0118
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: July 6, 2011
• Last updated: July 8, 2011
• Start date: November 2011
• Est. completion date: June 2015

Study information

• Verified date: April 2011
• Source: The Second People's Hospital of Chengdu
• Contact: Jian Xiong Liu, MD
• Phone: 862886621522-5205
• Email: steven.ljx[@]163.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationChina: Ministry of Science and TechnologyChina: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Device:
• THERMOCOOL® Catheter
Catheter-based renal denervation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Second People's Hospital of Chengdu

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Pressure Reduction	To confirm that renal denervation is safe, feasible and effective.	one year	Yes