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Trial record 1 of 20 for:    symplicity 2
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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

Brief Summary:
An international, multi-center, prospective, randomized, controlled study of the safety and effectiveness of renal denervation in patients with uncontrolled hypertension.

Condition or disease Intervention/treatment Phase
Uncontrolled Hypertension Device: Renal Denervation (Symplicity® Renal Denervation System) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Renal Denervation in Patients With Uncontrolled Hypertension (Symplicity HTN-2)
Study Start Date : June 2009
Actual Primary Completion Date : September 2010
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Renal Denervation
Renal Denervation and maintenance of anti-hypertensive medications
Device: Renal Denervation (Symplicity® Renal Denervation System)
Catheter-based renal denervation

No Intervention: Control
Maintenance of anti-hypertensive medications with option for cross-over treatment after 6-months



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00888433


Locations
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Sponsors and Collaborators
Medtronic Vascular
Investigators
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Principal Investigator: Murray Esler, MBBS The Baker IDI Heart & Diabetes Institute

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT00888433    
Other Study ID Numbers: TP-058
First Posted: April 27, 2009    Key Record Dates
Results First Posted: February 24, 2014
Last Update Posted: May 20, 2015
Last Verified: May 2015
Keywords provided by Medtronic Vascular:
hypertension
renal denervation
sympathetic nervous system
RDN
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases