SYMPLICITY HTN-3 Renal Denervation in Patients With Uncontrolled Hypertension
NCT ID: NCT01418261
Last Updated: 2017-04-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
535 participants
INTERVENTIONAL
2011-09-30
2017-02-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Renal Denervation
Subjects are treated with the renal denervation procedure after randomization and maintained baseline anti-hypertensive medications
Renal denervation (Symplicity Catheter System)
Renal angiogram
Control group
Subjects go through renal angiogram and Subjects maintained baseline anti-hypertensive medications
Renal angiogram
Interventions
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Renal denervation (Symplicity Catheter System)
Renal angiogram
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
80 Years
ALL
No
Sponsors
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Medtronic Vascular
INDUSTRY
Responsible Party
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Principal Investigators
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George Bakris, MD
Role: PRINCIPAL_INVESTIGATOR
Professor of Medicine, Hypertension Center Director University of Chicago Medical Center
Deepak L Bhatt, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
VA Boston Healthcare System Department of Cardiology
Locations
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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
Kaiser Permanente - Los Angeles Medical Center
Los Angeles, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
St. Joseph Hospital
Orange, California, United States
San Diego Cardiac Center
San Diego, California, United States
Stanford University
Stanford, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Howard University Hospital
Washington D.C., District of Columbia, United States
Shands / University of Florida
Gainesville, Florida, United States
Mayo Clinic
Jacksonville, Florida, United States
University Of Miami
Miami, Florida, United States
Baptist Cardiac &Vascular Institute, Baptist Health Systems
Miami, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Emory University Hospital Midtown
Atlanta, Georgia, United States
Piedmont Heart Institute
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Midwest Heart Foundation
Oakbrook Terrace, Illinois, United States
Prairie Heart Institute
Springfield, Illinois, United States
Iowa Heart Center Research
Des Moines, Iowa, United States
University of Kentucky
Lexington, Kentucky, United States
Ochsner Medical Center
New Orleans, Louisiana, United States
University of Maryland, Baltimore
Baltimore, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
VA Boston Healthcare System
Boston, Massachusetts, United States
Lahey Clinic
Burlington, Massachusetts, United States
UMass Memorial Medical Center
Worcester, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Harper University Hospital - Detroit Medical Center
Detroit, Michigan, United States
St Joseph Mercy Oakland Hospital
Pontiac, Michigan, United States
Providence Hospital
Southfield, Michigan, United States
Michigan Heart, St. Joseph Mercy Health System
Ypsilanti, Michigan, United States
Abbott Northwestern/Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States
Saint Mary's Mayo Clinic
Rochester, Minnesota, United States
Hattiesburg Clinic, P.A
Hattiesburg, Mississippi, United States
Saint Luke's Hospital of Kansas City/Mid America Heart Institute
Kansas City, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Deborah Heart & Lung Center
Browns Mills, New Jersey, United States
Morristown Medical Center
Morristown, New Jersey, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, United States
SUNY Downstate Medical Center
Brooklyn, New York, United States
New York University Medical Center
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
Mount Sinai Medical Center-Manhattan
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
St. Francis Hospital
Roslyn, 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
Carolinas Healthcare (SHVI)-Clinical Research
Charlotte, North Carolina, United States
Duke University Health System
Durham, North Carolina, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
The Lindner Center for Research & Education at The Christ Hospital
Cincinnati, Ohio, United States
University Hospitals Case Medical Center
Cleveland, Ohio, United States
The MetroHealth System
Cleveland, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
OhioHealth Research Institute
Columbus, Ohio, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Lancaster General Hospital
Lancaster, Pennsylvania, United States
Thomas Jefferson University Hospitals, Inc
Philadelphia, Pennsylvania, United States
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States
UPMC
Pittsburgh, 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
Vanderbilt Medical Center
Nashville, Tennessee, United States
Austin Heart PLLC / Heart Hospital of Austin
Austin, Texas, 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
Virginia Commonwealth University
Richmond, Virginia, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States
Countries
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References
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Bhatt DL, Vaduganathan M, Kandzari DE, Leon MB, Rocha-Singh K, Townsend RR, Katzen BT, Oparil S, Brar S, DeBruin V, Fahy M, Bakris GL; SYMPLICITY HTN-3 Steering Committee Investigators. Long-term outcomes after catheter-based renal artery denervation for resistant hypertension: final follow-up of the randomised SYMPLICITY HTN-3 Trial. Lancet. 2022 Oct 22;400(10361):1405-1416. doi: 10.1016/S0140-6736(22)01787-1. Epub 2022 Sep 18.
Mahfoud F, Bakris G, Bhatt DL, Esler M, Ewen S, Fahy M, Kandzari D, Kario K, Mancia G, Weber M, Bohm M. Reduced blood pressure-lowering effect of catheter-based renal denervation in patients with isolated systolic hypertension: data from SYMPLICITY HTN-3 and the Global SYMPLICITY Registry. Eur Heart J. 2017 Jan 7;38(2):93-100. doi: 10.1093/eurheartj/ehw325.
Pocock SJ, Bakris G, Bhatt DL, Brar S, Fahy M, Gersh BJ. Regression to the Mean in SYMPLICITY HTN-3: Implications for Design and Reporting of Future Trials. J Am Coll Cardiol. 2016 Nov 1;68(18):2016-2025. doi: 10.1016/j.jacc.2016.07.775.
Kario K, Bhatt DL, Brar S, Cohen SA, Fahy M, Bakris GL. Effect of Catheter-Based Renal Denervation on Morning and Nocturnal Blood Pressure: Insights From SYMPLICITY HTN-3 and SYMPLICITY HTN-Japan. Hypertension. 2015 Dec;66(6):1130-7. doi: 10.1161/HYPERTENSIONAHA.115.06260. Epub 2015 Oct 5.
Bakris GL, Townsend RR, Flack JM, Brar S, Cohen SA, D'Agostino R, Kandzari DE, Katzen BT, Leon MB, Mauri L, Negoita M, O'Neill WW, Oparil S, Rocha-Singh K, Bhatt DL; SYMPLICITY HTN-3 Investigators. 12-month blood pressure results of catheter-based renal artery denervation for resistant hypertension: the SYMPLICITY HTN-3 trial. J Am Coll Cardiol. 2015 Apr 7;65(13):1314-1321. doi: 10.1016/j.jacc.2015.01.037.
Kandzari DE, Bhatt DL, Brar S, Devireddy CM, Esler M, Fahy M, Flack JM, Katzen BT, Lea J, Lee DP, Leon MB, Ma A, Massaro J, Mauri L, Oparil S, O'Neill WW, Patel MR, Rocha-Singh K, Sobotka PA, Svetkey L, Townsend RR, Bakris GL. Predictors of blood pressure response in the SYMPLICITY HTN-3 trial. Eur Heart J. 2015 Jan 21;36(4):219-27. doi: 10.1093/eurheartj/ehu441. Epub 2014 Nov 16.
Bakris GL, Townsend RR, Liu M, Cohen SA, D'Agostino R, Flack JM, Kandzari DE, Katzen BT, Leon MB, Mauri L, Negoita M, O'Neill WW, Oparil S, Rocha-Singh K, Bhatt DL; SYMPLICITY HTN-3 Investigators. Impact of renal denervation on 24-hour ambulatory blood pressure: results from SYMPLICITY HTN-3. J Am Coll Cardiol. 2014 Sep 16;64(11):1071-8. doi: 10.1016/j.jacc.2014.05.012. Epub 2014 May 20.
Bhatt DL, Kandzari DE, O'Neill WW, D'Agostino R, Flack JM, Katzen BT, Leon MB, Liu M, Mauri L, Negoita M, Cohen SA, Oparil S, Rocha-Singh K, Townsend RR, Bakris GL; SYMPLICITY HTN-3 Investigators. A controlled trial of renal denervation for resistant hypertension. N Engl J Med. 2014 Apr 10;370(15):1393-401. doi: 10.1056/NEJMoa1402670. Epub 2014 Mar 29.
Other Identifiers
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IP125
Identifier Type: -
Identifier Source: org_study_id
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