SYMPLICITY HTN-3 Renal Denervation in Patients With Uncontrolled Hypertension

NCT01418261 | Completed DMC

• 1 other identifier: IP125
• Study Type: interventional
• Target: 535
• Locations: 1 country
• Sites: 79

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.

Conditions

Uncontrolled Hypertension

Keywords

uncontrolled hypertension; renal denervation

Outcome Measures

Primary Outcomes (1)

• Change in Office Systolic Blood Pressure

  Primary Effectiveness Outcome Measure

  Baseline to 6 months post-randomization

Secondary Outcomes (1)

• Change in average 24-hour Systolic Blood Pressure by ambulatory blood pressure monitoring

  Baseline to 6 months

Study Arms (2)

Renal Denervation

EXPERIMENTAL

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

Control group

SHAM COMPARATOR

Subjects go through renal angiogram and Subjects maintained baseline anti-hypertensive medications

Diagnostic Test: Renal angiogram

Interventions

Renal denervation (Symplicity Catheter System) DEVICE

Renal Denervation

Renal angiogram DIAGNOSTIC_TEST

Control group; Renal Denervation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic Vascular: lead

Study Sites (79)

Cardiology, PC

Birmingham, Alabama, 35211, United States

Location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Scripps Clinic/Scripps Green Hospital

La Jolla, California, 92037, United States

Location

Kaiser Permanente - Los Angeles Medical Center

Los Angeles, California, 90027, United States

Location

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

St. Joseph Hospital

Orange, California, 92868, United States

Location

San Diego Cardiac Center

San Diego, California, 92123, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Howard University Hospital

Washington D.C., District of Columbia, 20060, United States

Location

Shands / University of Florida

Gainesville, Florida, 32610, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

University Of Miami

Miami, Florida, 33136, United States

Location

Baptist Cardiac &Vascular Institute, Baptist Health Systems

Miami, Florida, 33176, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Midwest Heart Foundation

Oakbrook Terrace, Illinois, 60181, United States

Location

Prairie Heart Institute

Springfield, Illinois, 62701, United States

Location

Iowa Heart Center Research

Des Moines, Iowa, 50266, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

Location

University of Maryland, Baltimore

Baltimore, Maryland, 21201, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

VA Boston Healthcare System

Boston, Massachusetts, 02132, United States

Location

Lahey Clinic

Burlington, Massachusetts, 01805, United States

Location

UMass Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Harper University Hospital - Detroit Medical Center

Detroit, Michigan, 48201, United States

Location

St Joseph Mercy Oakland Hospital

Pontiac, Michigan, 48341, United States

Location

Providence Hospital

Southfield, Michigan, 48075, United States

Location

Michigan Heart, St. Joseph Mercy Health System

Ypsilanti, Michigan, 48197, United States

Location

Abbott Northwestern/Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

Location

Saint Mary's Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Hattiesburg Clinic, P.A

Hattiesburg, Mississippi, 39401, United States

Location

Saint Luke's Hospital of Kansas City/Mid America Heart Institute

Kansas City, Missouri, 64111, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Deborah Heart & Lung Center

Browns Mills, New Jersey, 08015, United States

Location

Morristown Medical Center

Morristown, New Jersey, 07962, United States

Location

Jersey Shore University Medical Center

Neptune City, New Jersey, 07753, United States

Location

SUNY Downstate Medical Center

Brooklyn, New York, 11203, United States

Location

New York University Medical Center

New York, New York, 10015, United States

Location

Weill Cornell Medical College

New York, New York, 10021, United States

Location

Mount Sinai Medical Center-Manhattan

New York, New York, 10029, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

St. Francis Hospital

Roslyn, New York, 11576, United States

Location

Stony Brook University Hospital and Medical Center

Stony Brook, New York, 11794, United States

Location

University of North Carolina Heart and Vascular

Chapel Hill, North Carolina, 27599, United States

Location

Carolinas Healthcare (SHVI)-Clinical Research

Charlotte, North Carolina, 28203, United States

Location

Duke University Health System

Durham, North Carolina, 27710, United States

Location

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

The Lindner Center for Research & Education at The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

The MetroHealth System

Cleveland, Ohio, 44109, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

OhioHealth Research Institute

Columbus, Ohio, 43214-3907, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Lancaster General Hospital

Lancaster, Pennsylvania, 17604, United States

Location

Thomas Jefferson University Hospitals, Inc

Philadelphia, Pennsylvania, 19107, United States

Location

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19130, United States

Location

UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Lankenau Medical Center

Wynnewood, Pennsylvania, 19096, United States

Location

Vascular Disease Research Center at Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Stern Cardiovascular Foundation, Inc.

Memphis, Tennessee, 38138, United States

Location

Vanderbilt Medical Center

Nashville, Tennessee, 37232-7235, United States

Location

Austin Heart PLLC / Heart Hospital of Austin

Austin, Texas, 78756, United States

Location

VA North Texas Health Care System

Dallas, Texas, 75216, United States

Location

Soltero Cardiovascular Research Center - Baylor Jack and Jane Hamilton Heart & Vascular Hospital

Dallas, Texas, 75226, United States

Location

The Methodist Hospital

Houston, Texas, 77030, United States

Location

The Heart Hospital Baylor Plano

Plano, Texas, 75093, United States

Location

Fletcher Allen Health Care

Burlington, Vermont, 05401, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

Related Publications (8)

• 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.

  PMID: 36130612 DERIVED

• 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.

  PMID: 28158510 DERIVED

• 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.

  PMID: 27788856 DERIVED

• 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.

  PMID: 26558819 DERIVED

• 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.

  PMID: 25835443 DERIVED

• 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.

  PMID: 25400162 DERIVED

• 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.

  PMID: 24858423 DERIVED

• 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.

  PMID: 24678939 DERIVED

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2011
• First Posted: August 17, 2011
• Study Start: September 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: February 17, 2017
• Last Updated: April 26, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (79)