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Renal Denervation in Patients With Uncontrolled Hypertension (Symplicity HTN-2) (HTN-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00888433
Recruitment Status : Completed
First Posted : April 27, 2009
Results First Posted : February 24, 2014
Last Update Posted : May 20, 2015
Sponsor:
Information provided by (Responsible Party):
Medtronic Vascular

Tracking Information
First Submitted Date  ICMJE April 24, 2009
First Posted Date  ICMJE April 27, 2009
Results First Submitted Date  ICMJE September 13, 2013
Results First Posted Date  ICMJE February 24, 2014
Last Update Posted Date May 20, 2015
Study Start Date  ICMJE June 2009
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2014)
Office Systolic Blood Pressure Reduction [ Time Frame: Baseline to 6 months ]
The primary effectiveness endpoint is change in Office Systolic Blood Pressure (SBP) from baseline to 6 months post-randomization.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00888433 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Renal Denervation in Patients With Uncontrolled Hypertension (Symplicity HTN-2)
Official Title  ICMJE Renal Denervation in Patients With Uncontrolled Hypertension (Symplicity HTN-2)
Brief Summary An international, multi-center, prospective, randomized, controlled study of the safety and effectiveness of renal denervation in patients with uncontrolled hypertension.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Uncontrolled Hypertension
Intervention  ICMJE Device: Renal Denervation (Symplicity® Renal Denervation System)
Catheter-based renal denervation
Study Arms  ICMJE
  • Experimental: Renal Denervation
    Renal Denervation and maintenance of anti-hypertensive medications
    Intervention: Device: Renal Denervation (Symplicity® Renal Denervation System)
  • No Intervention: Control
    Maintenance of anti-hypertensive medications with option for cross-over treatment after 6-months
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 7, 2010)
106
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE May 2015
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • systolic blood pressure >=160mmHg (>=150 mmHg for type 2 diabetics);
  • on 3 or more antihypertensive medications
  • >= 18 and =< 85 years of age.

Exclusion Criteria:

  • renal artery abnormalities
  • eGFR < 45mL/min
  • MI, angina, CVA within 6 months
  • Type 1 diabetes
  • ICD or pacemaker, or any other metallic implant not compatible with MRI
  • others
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   France,   Germany,   Latvia,   Poland,   Spain,   Switzerland,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00888433
Other Study ID Numbers  ICMJE TP-058
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medtronic Vascular
Study Sponsor  ICMJE Medtronic Vascular
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Murray Esler, MBBS The Baker IDI Heart & Diabetes Institute
PRS Account Medtronic Vascular
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP