Renal Denervation in Patients With Uncontrolled Hypertens... | NCT01390831

Studies
Renal Denervation in Patients With Uncontrolled Hypertension in Chinese

NCT01390831

Sponsor

The Second People's Hospital of Chengdu

Status

Unknown status

Last Update Posted

Jul 11, 2011Estimated

Enrollment

100Estimated

Phase

Phase 1Phase 2

Conditions

Hypertension

Interventions

THERMOCOOL® Catheter

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2011

Primary Completion Date

Nov 2014Estimated

Completion Date

Jun 2015Estimated

First Submitted Date

Jul 6, 2011

First Submission Date that Met QC Criteria

Jul 8, 2011

First Posted Date

Jul 11, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 8, 2011

Last Update Posted Date

Jul 11, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Catheter, Renal Denervation, Ablation	Experimental	Catheter-based renal denervation and maintenance of anti-hypertensive medications	Device: THERMOCOOL® Catheter
anti-hypertensive medications	No Intervention	Maintenance of anti-hypertensive medications

Interventions

Name	Type	Description	Arm Group Labels	Other Names
THERMOCOOL® Catheter	Device	Catheter-based renal denervation	Catheter, Renal Denervation, Ablation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood Pressure Reduction	To confirm that renal denervation is safe, feasible and effective.	one year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jian Xiong Liu, MD	Contact	862886621522-5205		steven.ljx@163.com

Overall Officials

Name	Affiliation	Role
Jian Xiong Liu	The Second People's Hospital of Chengdu	Principal Investigator

Locations

Not provided

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases