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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic Vascular
ClinicalTrials.gov Identifier:
NCT01418261
First received: August 15, 2011
Last updated: October 3, 2014
Last verified: October 2014
  Purpose

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 Intervention Phase
Uncontrolled Hypertension
Device: Renal denervation (Symplicity Catheter System)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Medtronic Vascular:

Primary Outcome Measures:
  • Change in Office Systolic Blood Pressure [ Time Frame: Baseline to 6 months post-randomization ] [ Designated as safety issue: No ]
    Primary Effectiveness Outcome Measure

  • Incidence of Major Adverse Events through 1 month post-randomization (Renal artery stenosis measured at 6 months) [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in average 24-hour Systolic Blood Pressure by ambulatory blood pressure monitoring [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 530
Study Start Date: September 2011
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Renal Denervation
Subjects are treated with the renal denervation procedure after randomization and are maintained on baseline anti-hypertensive medications
Device: Renal denervation (Symplicity Catheter System)
Symplicity Catheter System
No Intervention: Control group
Subjects are maintained on baseline anti-hypertensive medications

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01418261

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

No publications provided by Medtronic Vascular

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT01418261     History of Changes
Other Study ID Numbers: IP125
Study First Received: August 15, 2011
Last Updated: October 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Medtronic Vascular:
uncontrolled hypertension
renal denervation

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014