NCT01390831

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for phase_1 hypertension

Timeline
Completed

Started Nov 2011

Longer than P75 for phase_1 hypertension

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 11, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

July 11, 2011

Status Verified

April 1, 2011

Enrollment Period

3 years

First QC Date

July 6, 2011

Last Update Submit

July 8, 2011

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Blood Pressure Reduction

    To confirm that renal denervation is safe, feasible and effective.

    one year

Study Arms (2)

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

THERMOCOOL® CatheterDEVICE

Catheter-based renal denervation

Catheter, Renal Denervation, Ablation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>= 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Jian Xiong Liu

    The Second People's Hospital of Chengdu

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian Xiong Liu, MD

CONTACT

862886621522-5205steven.ljx@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 6, 2011

First Posted

July 11, 2011

Study Start

November 1, 2011

Primary Completion

November 1, 2014

Study Completion

June 1, 2015

Last Updated

July 11, 2011

Record last verified: 2011-04