Trial record 1 of 1 for:
Symplicity HTN-3: Renal Denervation in Patients With Uncontrolled Hypertension
Renal Denervation in Patients With Uncontrolled Hypertension (SYMPLICITY HTN-3)
This study is ongoing, but not recruiting participants.
Sponsor:
Medtronic Vascular
Information provided by (Responsible Party):
Medtronic Vascular
ClinicalTrials.gov Identifier:
NCT01418261
First received: August 15, 2011
Last updated: May 29, 2013
Last verified: May 2013
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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 |
| Estimated Primary Completion Date: | January 2014 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01418261
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| United States, Alabama | |
| Cardiology, PC | |
| Birmingham, Alabama, United States, 35211 | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| United States, California | |
| Scripps Clinic/Scripps Green Hospital | |
| La Jolla, California, United States, 92037 | |
| Cedars Sinai Medical Center | |
| Los Angeles, California, United States, 90048 | |
| Kaiser Permanente - Los Angeles Medical Center | |
| Los Angeles, California, United States, 90027 | |
| 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, Connecticut | |
| Pat and Jim Calhoun Cardiology Center - University of Connecticut Health Center | |
| Farmington, Connecticut, United States, 06030-2202 | |
| United States, District of Columbia | |
| MedStar Washington Hospital Center | |
| Washington, District of Columbia, United States, 20010 | |
| Howard University Hospital | |
| Washington, District of Columbia, United States, 20060 | |
| George Washington University Hospital | |
| Washington, District of Columbia, United States, 20037 | |
| United States, Florida | |
| Shands / University of Florida | |
| Gainesville, Florida, United States, 32610 | |
| Mayo Clinic | |
| Jacksonville, Florida, United States, 32224 | |
| University Of Miami | |
| Miami, Florida, United States, 33136 | |
| Baptist Cardiac &Vascular Institute, Baptist Health Systems | |
| Miami, Florida, United States, 33176 | |
| 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 | |
| University of Chicago | |
| Chicago, Illinois, United States, 60637 | |
| Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| 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 | |
| Montefiore Medical Center | |
| Bronx, New York, United States, 10467 | |
| SUNY Downstate Medical Center | |
| Brooklyn, New York, United States, 11203 | |
| Columbia University Medical Center | |
| New York, New York, United States, 10032 | |
| 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 | |
| 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 | |
| Cleveland Clinic Foundation | |
| Cleveland, Ohio, United States, 44195 | |
| University Hospitals Case Medical Center | |
| Cleveland, Ohio, United States, 44106 | |
| 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 | |
| Memorial Research Center/ Chattanooga Heart Institute | |
| Chattanooga, Tennessee, United States, 37404 | |
| 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 | |
| University of Texas Southwestern Medical Center | |
| Dallas, Texas, United States, 75390 | |
| 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 | |
| University of Texas Health Science Center at Houston | |
| Houston, Texas, United States, 77030 | |
| The Methodist Hospital | |
| Houston, Texas, United States, 77030 | |
| The Heart Hospital Baylor Plano | |
| Plano, Texas, United States, 75093 | |
| Scott & White Healthcare | |
| Temple, Texas, United States, 76508 | |
| 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, Washington | |
| Providence Medical Research Center | |
| Spokane, Washington, United States, 99204 | |
| United States, Wisconsin | |
| Aurora St. Luke's Medical Center | |
| Milwaukee, Wisconsin, United States, 53215 | |
| Wheaton Franciscan Healthcare-All Saints | |
| Racine, Wisconsin, United States, 53405 | |
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
| Responsible Party: | Medtronic Vascular |
| ClinicalTrials.gov Identifier: | NCT01418261 History of Changes |
| Other Study ID Numbers: | IP125 |
| Study First Received: | August 15, 2011 |
| Last Updated: | May 29, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Medtronic Vascular:
|
uncontrolled hypertension renal denervation |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on June 17, 2013