Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

SYMPLICITY HTN-3 Renal Denervation in Patients With Uncontrolled Hypertension

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: NCT01418261
Recruitment Status : Completed
First Posted : August 17, 2011
Last Update Posted : April 26, 2017
Sponsor:
Information provided by (Responsible Party):
Medtronic Vascular

Tracking Information
First Submitted Date  ICMJE August 15, 2011
First Posted Date  ICMJE August 17, 2011
Last Update Posted Date April 26, 2017
Study Start Date  ICMJE September 2011
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 21, 2017)
Change in Office Systolic Blood Pressure [ Time Frame: Baseline to 6 months post-randomization ]
Primary Effectiveness Outcome Measure
Original Primary Outcome Measures  ICMJE
 (submitted: August 16, 2011)
  • Change in Office Systolic Blood Pressure [ Time Frame: Baseline to 6 months post-randomization ]
    Primary Effectiveness Outcome Measure
  • Major Adverse Events [ Time Frame: Baseline to 1 month post-randomization ]
    Primary Safety Outcome Measure
Change History Complete list of historical versions of study NCT01418261 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 16, 2011)
Change in average 24-hour Systolic Blood Pressure by ambulatory blood pressure monitoring [ Time Frame: Baseline to 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SYMPLICITY HTN-3 Renal Denervation in Patients With Uncontrolled Hypertension
Official Title  ICMJE Renal Denervation in Patients With Uncontrolled Hypertension (SYMPLICITY HTN-3)
Brief Summary The Symplicity HTN-3 study is a, multi-center, prospective, single-blind, randomized, controlled study of the safety and effectiveness of renal denervation in subjects with uncontrolled hypertension. Bilateral renal denervation will be performed using the Symplicity Catheter - a percutaneous system that delivers radiofrequency (RF)energy through the luminal surface of the renal artery.
Detailed Description The Symplicity HTN-3 study is a, multi-center, prospective, single-blind, randomized, controlled study of the safety and effectiveness of renal denervation in subjects with uncontrolled hypertension. Bilateral renal denervation will be performed using the Symplicity Catheter - a percutaneous system that delivers radiofrequency (RF)energy through the luminal surface of the renal artery.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Uncontrolled Hypertension
Intervention  ICMJE
  • Device: Renal denervation (Symplicity Catheter System)
  • Diagnostic Test: Renal angiogram
Study Arms  ICMJE
  • Experimental: Renal Denervation
    Subjects are treated with the renal denervation procedure after randomization and maintained baseline anti-hypertensive medications
    Interventions:
    • Device: Renal denervation (Symplicity Catheter System)
    • Diagnostic Test: Renal angiogram
  • Sham Comparator: Control group
    Subjects go through renal angiogram and Subjects maintained baseline anti-hypertensive medications
    Intervention: Diagnostic Test: Renal angiogram
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: March 21, 2017)
535
Original Estimated Enrollment  ICMJE
 (submitted: August 16, 2011)
530
Actual Study Completion Date  ICMJE February 17, 2017
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Individual is ≥ 18 and ≤ 80 years old at time of randomization.
  • Individual is receiving a stable medication regimen including full tolerated doses of 3 or more anti-hypertensive medications of different classes, of which one must be a diuretic (with no changes for a minimum of 2 weeks prior to screening) that is expected to be maintained without changes for at least 6 months.
  • Individual has an office systolic blood pressure (SBP) of ≥ 160 mmHg based on an average of 3 blood pressure readings measured at both an initial screening visit and a confirmatory screening visit

Exclusion Criteria:

  • Individual has an estimated glomerular filtration rate (eGFR) of < 45 mL/min/1.73 m2
  • Individual has an Ambulatory Blood Pressure Monitoring (ABPM) 24 hour average SBP < 135 mmHg
  • Individual has type 1 diabetes mellitus
  • Individual requires chronic oxygen support or mechanical ventilation (e.g., tracheostomy, CPAP, BiPAP) other than nocturnal respiratory support for sleep apnea.
  • Individual has primary pulmonary hypertension.
  • Individual is pregnant, nursing or planning to be pregnant.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01418261
Other Study ID Numbers  ICMJE IP125
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Medtronic Vascular
Study Sponsor  ICMJE Medtronic Vascular
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: George Bakris, MD Professor of Medicine, Hypertension Center Director University of Chicago Medical Center
Principal Investigator: Deepak L Bhatt, MD, MPH VA Boston Healthcare System Department of Cardiology
PRS Account Medtronic Vascular
Verification Date April 2017

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