SYMPLICITY HTN-3 Renal Denervation in Patients With Uncontrolled Hypertension

April 24, 2017 updated by: Medtronic Vascular

Renal Denervation in Patients With Uncontrolled Hypertension (SYMPLICITY HTN-3)

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

535

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
      • Birmingham, Alabama, United States, 35211
        • Cardiology, PC
    • California
      • La Jolla, California, United States, 92037
        • Scripps Clinic/Scripps Green Hospital
      • Los Angeles, California, United States, 90048
        • Cedars Sinai Medical Center
      • Los Angeles, California, United States, 90027
        • Kaiser Permanente - Los Angeles Medical Center
      • Orange, California, United States, 92868
        • St. Joseph Hospital
      • San Diego, California, United States, 92123
        • San Diego Cardiac Center
      • Stanford, California, United States, 94305
        • Stanford University
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital
    • District of Columbia
      • Washington, D.C., District of Columbia, United States, 20060
        • Howard University Hospital
      • Washington, D.C., District of Columbia, United States, 20010
        • Medstar Washington Hospital Center
    • Florida
      • Gainesville, Florida, United States, 32610
        • Shands / University of Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic
      • Miami, Florida, United States, 33136
        • University of Miami
      • Miami, Florida, United States, 33176
        • Baptist Cardiac &Vascular Institute, Baptist Health Systems
      • Tampa, Florida, United States, 33606
        • Tampa General Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Emory University Hospital Midtown
      • Atlanta, Georgia, United States, 30309
        • Piedmont Heart Institute
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Chicago, Illinois, United States, 60637
        • University of Chicago
      • Oakbrook Terrace, Illinois, United States, 60181
        • Midwest Heart Foundation
      • Springfield, Illinois, United States, 62701
        • Prairie Heart Institute
    • Iowa
      • Des Moines, Iowa, United States, 50266
        • Iowa Heart Center Research
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland, Baltimore
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02132
        • VA Boston Healthcare System
      • Burlington, Massachusetts, United States, 01805
        • Lahey Clinic
      • Worcester, Massachusetts, United States, 01655
        • UMass Memorial Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
      • Detroit, Michigan, United States, 48201
        • Harper University Hospital - Detroit Medical Center
      • Pontiac, Michigan, United States, 48341
        • St Joseph Mercy Oakland Hospital
      • Southfield, Michigan, United States, 48075
        • Providence Hospital
      • Ypsilanti, Michigan, United States, 48197
        • Michigan Heart, St. Joseph Mercy Health System
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Abbott Northwestern/Minneapolis Heart Institute Foundation
      • Rochester, Minnesota, United States, 55905
        • Saint Mary's Mayo Clinic
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
        • Hattiesburg Clinic, P.A
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Saint Luke's Hospital of Kansas City/Mid America Heart Institute
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New Jersey
      • Browns Mills, New Jersey, United States, 08015
        • Deborah Heart & Lung Center
      • Morristown, New Jersey, United States, 07962
        • Morristown Medical Center
      • Neptune City, New Jersey, United States, 07753
        • Jersey Shore University Medical Center
    • New York
      • Brooklyn, New York, United States, 11203
        • SUNY Downstate Medical Center
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • New York, New York, United States, 10021
        • Weill Cornell Medical College
      • New York, New York, United States, 10015
        • New York University Medical Center
      • New York, New York, United States, 10029
        • Mount Sinai Medical Center-Manhattan
      • Roslyn, New York, United States, 11576
        • St. Francis Hospital
      • Stony Brook, New York, United States, 11794
        • Stony Brook University Hospital and Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina Heart and Vascular
      • Charlotte, North Carolina, United States, 28203
        • Carolinas Healthcare (SHVI)-Clinical Research
      • Durham, North Carolina, United States, 27710
        • Duke University Health System
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Baptist Health
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • The Lindner Center for Research & Education at The Christ Hospital
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Cleveland, Ohio, United States, 44109
        • The MetroHealth System
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Case Medical Center
      • Columbus, Ohio, United States, 43210
        • The Ohio State University
      • Columbus, Ohio, United States, 43214-3907
        • OhioHealth Research Institute
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Medical Center
      • Lancaster, Pennsylvania, United States, 17604
        • Lancaster General Hospital
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospitals, Inc
      • Philadelphia, Pennsylvania, United States, 19130
        • University of Pennsylvania Health System
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC
      • Wynnewood, Pennsylvania, United States, 19096
        • Lankenau Medical Center
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Vascular Disease Research Center at Rhode Island Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Tennessee
      • Memphis, Tennessee, United States, 38138
        • Stern Cardiovascular Foundation, Inc.
      • Nashville, Tennessee, United States, 37232-7235
        • Vanderbilt Medical Center
    • Texas
      • Austin, Texas, United States, 78756
        • Austin Heart PLLC / Heart Hospital of Austin
      • Dallas, Texas, United States, 75216
        • VA North Texas Health Care System
      • Dallas, Texas, United States, 75226
        • Soltero Cardiovascular Research Center - Baylor Jack and Jane Hamilton Heart & Vascular Hospital
      • Houston, Texas, United States, 77030
        • The Methodist Hospital
      • Plano, Texas, United States, 75093
        • The Heart Hospital Baylor Plano
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Fletcher Allen Health Care
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Aurora St. Luke's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Office Systolic Blood Pressure
Time Frame: Baseline to 6 months post-randomization
Primary Effectiveness Outcome Measure
Baseline to 6 months post-randomization

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in average 24-hour Systolic Blood Pressure by ambulatory blood pressure monitoring
Time Frame: Baseline to 6 months
Baseline to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Vascular

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

February 17, 2017

Study Registration Dates

First Submitted

August 15, 2011

First Submitted That Met QC Criteria

August 16, 2011

First Posted (ESTIMATE)

August 17, 2011

Study Record Updates

Last Update Posted (ACTUAL)

April 26, 2017

Last Update Submitted That Met QC Criteria

April 24, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IP125

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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