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SYMPLICITY HTN-3 Renal Denervation in Patients With Uncontrolled Hypertension

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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Uncontrolled Hypertension Device: Renal denervation (Symplicity Catheter System) Diagnostic Test: Renal angiogram Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 535 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Renal Denervation in Patients With Uncontrolled Hypertension (SYMPLICITY HTN-3)
Study Start Date : September 2011
Actual Primary Completion Date : December 2013
Actual Study Completion Date : February 17, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Renal Denervation
Subjects are treated with the renal denervation procedure after randomization and maintained baseline anti-hypertensive medications
 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
 Diagnostic Test: Renal angiogram


Outcome Measures
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Primary Outcome Measures :
  1. Change in Office Systolic Blood Pressure [ Time Frame: Baseline to 6 months post-randomization ]
    Primary Effectiveness Outcome Measure


Secondary Outcome Measures :
  1. Change in average 24-hour Systolic Blood Pressure by ambulatory blood pressure monitoring [ Time Frame: Baseline to 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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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): NCT01418261


Locations
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Sponsors and Collaborators
Medtronic Vascular
Investigators
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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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT01418261    
Other Study ID Numbers: IP125
First Posted: August 17, 2011    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Medtronic Vascular:
uncontrolled hypertension
renal denervation
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases