SYMPLICITY HTN-3 Renal Denervation in Patients With Uncontrolled Hypertension

Uncontrolled Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01418261
• Other study ID #: IP125
• Status: Completed
• Phase: N/A
• First received: August 15, 2011
• Last updated: April 24, 2017
• Start date: September 2011
• Est. completion date: February 17, 2017

Study information

• Verified date: April 2017
• Source: Medtronic Vascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 535
• Est. completion date: February 17, 2017
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Uncontrolled Hypertension

Intervention

Device:
• Renal denervation (Symplicity Catheter System)

Diagnostic Test:
• Renal angiogram

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory University Hospital Midtown	Atlanta	Georgia
United States	Piedmont Heart Institute	Atlanta	Georgia
United States	University of Colorado Hospital	Aurora	Colorado
United States	Austin Heart PLLC / Heart Hospital of Austin	Austin	Texas
United States	University of Maryland, Baltimore	Baltimore	Maryland
United States	Cardiology, PC	Birmingham	Alabama
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	VA Boston Healthcare System	Boston	Massachusetts
United States	SUNY Downstate Medical Center	Brooklyn	New York
United States	Deborah Heart & Lung Center	Browns Mills	New Jersey
United States	Fletcher Allen Health Care	Burlington	Vermont
United States	Lahey Clinic	Burlington	Massachusetts
United States	University of North Carolina Heart and Vascular	Chapel Hill	North Carolina
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Carolinas Healthcare (SHVI)-Clinical Research	Charlotte	North Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	Northwestern University	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	The Lindner Center for Research & Education at The Christ Hospital	Cincinnati	Ohio
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	The MetroHealth System	Cleveland	Ohio
United States	University Hospitals Case Medical Center	Cleveland	Ohio
United States	OhioHealth Research Institute	Columbus	Ohio
United States	The Ohio State University	Columbus	Ohio
United States	Soltero Cardiovascular Research Center - Baylor Jack and Jane Hamilton Heart & Vascular Hospital	Dallas	Texas
United States	VA North Texas Health Care System	Dallas	Texas
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Iowa Heart Center Research	Des Moines	Iowa
United States	Harper University Hospital - Detroit Medical Center	Detroit	Michigan
United States	Duke University Health System	Durham	North Carolina
United States	Shands / University of Florida	Gainesville	Florida
United States	Hattiesburg Clinic, P.A	Hattiesburg	Mississippi
United States	The Methodist Hospital	Houston	Texas
United States	Mayo Clinic	Jacksonville	Florida
United States	Saint Luke's Hospital of Kansas City/Mid America Heart Institute	Kansas City	Missouri
United States	Scripps Clinic/Scripps Green Hospital	La Jolla	California
United States	Lancaster General Hospital	Lancaster	Pennsylvania
United States	University of Kentucky	Lexington	Kentucky
United States	Cedars Sinai Medical Center	Los Angeles	California
United States	Kaiser Permanente - Los Angeles Medical Center	Los Angeles	California
United States	Stern Cardiovascular Foundation, Inc.	Memphis	Tennessee
United States	Baptist Cardiac &Vascular Institute, Baptist Health Systems	Miami	Florida
United States	University Of Miami	Miami	Florida
United States	Aurora St. Luke's Medical Center	Milwaukee	Wisconsin
United States	Abbott Northwestern/Minneapolis Heart Institute Foundation	Minneapolis	Minnesota
United States	Morristown Medical Center	Morristown	New Jersey
United States	Vanderbilt Medical Center	Nashville	Tennessee
United States	Jersey Shore University Medical Center	Neptune City	New Jersey
United States	Ochsner Medical Center	New Orleans	Louisiana
United States	Columbia University Medical Center	New York	New York
United States	Mount Sinai Medical Center-Manhattan	New York	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	Midwest Heart Foundation	Oakbrook Terrace	Illinois
United States	St. Joseph Hospital	Orange	California
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	The Heart Hospital Baylor Plano	Plano	Texas
United States	St Joseph Mercy Oakland Hospital	Pontiac	Michigan
United States	Vascular Disease Research Center at Rhode Island Hospital	Providence	Rhode Island
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Saint Mary's Mayo Clinic	Rochester	Minnesota
United States	St. Francis Hospital	Roslyn	New York
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	San Diego Cardiac Center	San Diego	California
United States	Providence Hospital	Southfield	Michigan
United States	Prairie Heart Institute	Springfield	Illinois
United States	Stanford University	Stanford	California
United States	Stony Brook University Hospital and Medical Center	Stony Brook	New York
United States	Tampa General Hospital	Tampa	Florida
United States	Howard University Hospital	Washington, D.C.	District of Columbia
United States	MedStar Washington Hospital Center	Washington, D.C.	District of Columbia
United States	Wake Forest Baptist Health	Winston-Salem	North Carolina
United States	UMass Memorial Medical Center	Worcester	Massachusetts
United States	Lankenau Medical Center	Wynnewood	Pennsylvania
United States	Michigan Heart, St. Joseph Mercy Health System	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Vascular

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Office Systolic Blood Pressure	Primary Effectiveness Outcome Measure	Baseline to 6 months post-randomization
Secondary	Change in average 24-hour Systolic Blood Pressure by ambulatory blood pressure monitoring		Baseline to 6 months