SYMPLICITY HTN-3 Renal Denervation in Patients With Uncontrolled Hypertension
- Conditions
- Uncontrolled Hypertension
- Interventions
- Diagnostic Test: Renal angiogramDevice: Renal denervation (Symplicity Catheter System)
- Registration Number
- NCT01418261
- Lead Sponsor
- Medtronic Vascular
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 535
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group Renal angiogram Subjects go through renal angiogram and Subjects maintained baseline anti-hypertensive medications Renal Denervation Renal angiogram Subjects are treated with the renal denervation procedure after randomization and maintained baseline anti-hypertensive medications Renal Denervation Renal denervation (Symplicity Catheter System) Subjects are treated with the renal denervation procedure after randomization and maintained baseline anti-hypertensive medications
- Primary Outcome Measures
Name Time Method Change in Office Systolic Blood Pressure Baseline to 6 months post-randomization Primary Effectiveness Outcome Measure
- Secondary Outcome Measures
Name Time Method Change in average 24-hour Systolic Blood Pressure by ambulatory blood pressure monitoring Baseline to 6 months
Trial Locations
- Locations (79)
Kaiser Permanente - Los Angeles Medical Center
🇺🇸Los Angeles, California, United States
University of Maryland, Baltimore
🇺🇸Baltimore, Maryland, United States
Lahey Clinic
🇺🇸Burlington, Massachusetts, United States
Providence Hospital
🇺🇸Southfield, Michigan, United States
The Ohio State University
🇺🇸Columbus, Ohio, United States
UPMC
🇺🇸Pittsburgh, Pennsylvania, United States
Baptist Cardiac &Vascular Institute, Baptist Health Systems
🇺🇸Miami, Florida, United States
VA Boston Healthcare System
🇺🇸Boston, Massachusetts, United States
Cardiology, PC
🇺🇸Birmingham, Alabama, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Scripps Clinic/Scripps Green Hospital
🇺🇸La Jolla, California, United States
Stanford University
🇺🇸Stanford, California, United States
St. Joseph Hospital
🇺🇸Orange, California, United States
MedStar Washington Hospital Center
🇺🇸Washington, D.C., District of Columbia, United States
Shands / University of Florida
🇺🇸Gainesville, Florida, United States
Howard University Hospital
🇺🇸Washington, D.C., District of Columbia, United States
Piedmont Heart Institute
🇺🇸Atlanta, Georgia, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
Emory University Hospital Midtown
🇺🇸Atlanta, Georgia, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Prairie Heart Institute
🇺🇸Springfield, Illinois, United States
Midwest Heart Foundation
🇺🇸Oakbrook Terrace, Illinois, United States
Ochsner Medical Center
🇺🇸New Orleans, Louisiana, United States
Iowa Heart Center Research
🇺🇸Des Moines, Iowa, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
UMass Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
St Joseph Mercy Oakland Hospital
🇺🇸Pontiac, Michigan, United States
Michigan Heart, St. Joseph Mercy Health System
🇺🇸Ypsilanti, Michigan, United States
Harper University Hospital - Detroit Medical Center
🇺🇸Detroit, Michigan, United States
Saint Mary's Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Hattiesburg Clinic, P.A
🇺🇸Hattiesburg, Mississippi, United States
Deborah Heart & Lung Center
🇺🇸Browns Mills, New Jersey, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Saint Luke's Hospital of Kansas City/Mid America Heart Institute
🇺🇸Kansas City, Missouri, United States
Morristown Medical Center
🇺🇸Morristown, New Jersey, United States
SUNY Downstate Medical Center
🇺🇸Brooklyn, New York, United States
New York University Medical Center
🇺🇸New York, New York, United States
Mount Sinai Medical Center-Manhattan
🇺🇸New York, New York, United States
Stony Brook University Hospital and Medical Center
🇺🇸Stony Brook, New York, United States
University of North Carolina Heart and Vascular
🇺🇸Chapel Hill, North Carolina, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
St. Francis Hospital
🇺🇸Roslyn, New York, United States
Carolinas Healthcare (SHVI)-Clinical Research
🇺🇸Charlotte, North Carolina, United States
The MetroHealth System
🇺🇸Cleveland, Ohio, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Wake Forest Baptist Health
🇺🇸Winston-Salem, North Carolina, United States
University Hospitals Case Medical Center
🇺🇸Cleveland, Ohio, United States
OhioHealth Research Institute
🇺🇸Columbus, Ohio, United States
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
Thomas Jefferson University Hospitals, Inc
🇺🇸Philadelphia, Pennsylvania, United States
University of Pennsylvania Health System
🇺🇸Philadelphia, Pennsylvania, United States
Lankenau Medical Center
🇺🇸Wynnewood, Pennsylvania, United States
Vascular Disease Research Center at Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Stern Cardiovascular Foundation, Inc.
🇺🇸Memphis, Tennessee, United States
Austin Heart PLLC / Heart Hospital of Austin
🇺🇸Austin, Texas, United States
Vanderbilt Medical Center
🇺🇸Nashville, Tennessee, United States
VA North Texas Health Care System
🇺🇸Dallas, Texas, United States
Soltero Cardiovascular Research Center - Baylor Jack and Jane Hamilton Heart & Vascular Hospital
🇺🇸Dallas, Texas, United States
The Methodist Hospital
🇺🇸Houston, Texas, United States
The Heart Hospital Baylor Plano
🇺🇸Plano, Texas, United States
Fletcher Allen Health Care
🇺🇸Burlington, Vermont, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Aurora St. Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
San Diego Cardiac Center
🇺🇸San Diego, California, United States
Abbott Northwestern/Minneapolis Heart Institute Foundation
🇺🇸Minneapolis, Minnesota, United States
Duke University Health System
🇺🇸Durham, North Carolina, United States
The Lindner Center for Research & Education at The Christ Hospital
🇺🇸Cincinnati, Ohio, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
University Of Miami
🇺🇸Miami, Florida, United States
Lancaster General Hospital
🇺🇸Lancaster, Pennsylvania, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
University of Colorado Hospital
🇺🇸Aurora, Colorado, United States
Cedars Sinai Medical Center
🇺🇸Los Angeles, California, United States
Jersey Shore University Medical Center
🇺🇸Neptune City, New Jersey, United States
Weill Cornell Medical College
🇺🇸New York, New York, United States
Mayo Clinic
🇺🇸Jacksonville, Florida, United States