SYMPLICITY HTN-3 Renal Denervation in Patients With Uncontrolled Hypertension

Sponsor

Medtronic Vascular (Industry)

Overall Status

Completed

CT.gov ID

NCT01418261

Collaborator

(none)

535

Enrollment

Locations

Arms

65.6

Duration (Months)

6.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Uncontrolled Hypertension	Device: Renal denervation (Symplicity Catheter System) Diagnostic Test: Renal angiogram	N/A

Detailed Description

Study Design

Study Type:

Interventional

Actual Enrollment :

535 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2011

Actual Primary Completion Date :

Dec 1, 2013

Actual Study Completion Date :

Feb 17, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Renal Denervation 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
Sham Comparator: Control group Subjects go through renal angiogram and Subjects maintained baseline anti-hypertensive medications	Diagnostic Test: Renal angiogram

Arm

Intervention/Treatment

Experimental: Renal Denervation

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

Sham Comparator: Control group

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

Diagnostic Test: Renal angiogram

Outcome Measures

Primary Outcome Measures

Change in Office Systolic Blood Pressure [Baseline to 6 months post-randomization]
Primary Effectiveness Outcome Measure

Secondary Outcome Measures

Change in average 24-hour Systolic Blood Pressure by ambulatory blood pressure monitoring [Baseline to 6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Cardiology, PC	Birmingham	Alabama	United States	35211
2	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294
3	Scripps Clinic/Scripps Green Hospital	La Jolla	California	United States	92037
4	Kaiser Permanente - Los Angeles Medical Center	Los Angeles	California	United States	90027
5	Cedars Sinai Medical Center	Los Angeles	California	United States	90048
6	St. Joseph Hospital	Orange	California	United States	92868
7	San Diego Cardiac Center	San Diego	California	United States	92123
8	Stanford University	Stanford	California	United States	94305
9	University of Colorado Hospital	Aurora	Colorado	United States	80045
10	MedStar Washington Hospital Center	Washington, D.C.	District of Columbia	United States	20010
11	Howard University Hospital	Washington, D.C.	District of Columbia	United States	20060
12	Shands / University of Florida	Gainesville	Florida	United States	32610
13	Mayo Clinic	Jacksonville	Florida	United States	32224
14	University Of Miami	Miami	Florida	United States	33136
15	Baptist Cardiac &Vascular Institute, Baptist Health Systems	Miami	Florida	United States	33176
16	Tampa General Hospital	Tampa	Florida	United States	33606
17	Emory University Hospital Midtown	Atlanta	Georgia	United States	30308
18	Piedmont Heart Institute	Atlanta	Georgia	United States	30309
19	Northwestern University	Chicago	Illinois	United States	60611
20	University of Chicago	Chicago	Illinois	United States	60637
21	Midwest Heart Foundation	Oakbrook Terrace	Illinois	United States	60181
22	Prairie Heart Institute	Springfield	Illinois	United States	62701
23	Iowa Heart Center Research	Des Moines	Iowa	United States	50266
24	University of Kentucky	Lexington	Kentucky	United States	40536
25	Ochsner Medical Center	New Orleans	Louisiana	United States	70121
26	University of Maryland, Baltimore	Baltimore	Maryland	United States	21201
27	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
28	VA Boston Healthcare System	Boston	Massachusetts	United States	02132
29	Lahey Clinic	Burlington	Massachusetts	United States	01805
30	UMass Memorial Medical Center	Worcester	Massachusetts	United States	01655
31	University of Michigan	Ann Arbor	Michigan	United States	48109
32	Harper University Hospital - Detroit Medical Center	Detroit	Michigan	United States	48201
33	St Joseph Mercy Oakland Hospital	Pontiac	Michigan	United States	48341
34	Providence Hospital	Southfield	Michigan	United States	48075
35	Michigan Heart, St. Joseph Mercy Health System	Ypsilanti	Michigan	United States	48197
36	Abbott Northwestern/Minneapolis Heart Institute Foundation	Minneapolis	Minnesota	United States	55407
37	Saint Mary's Mayo Clinic	Rochester	Minnesota	United States	55905
38	Hattiesburg Clinic, P.A	Hattiesburg	Mississippi	United States	39401
39	Saint Luke's Hospital of Kansas City/Mid America Heart Institute	Kansas City	Missouri	United States	64111
40	Washington University School of Medicine	Saint Louis	Missouri	United States	63110
41	Deborah Heart & Lung Center	Browns Mills	New Jersey	United States	08015
42	Morristown Medical Center	Morristown	New Jersey	United States	07962
43	Jersey Shore University Medical Center	Neptune City	New Jersey	United States	07753
44	SUNY Downstate Medical Center	Brooklyn	New York	United States	11203
45	New York University Medical Center	New York	New York	United States	10015
46	Weill Cornell Medical College	New York	New York	United States	10021
47	Mount Sinai Medical Center-Manhattan	New York	New York	United States	10029
48	Columbia University Medical Center	New York	New York	United States	10032
49	St. Francis Hospital	Roslyn	New York	United States	11576
50	Stony Brook University Hospital and Medical Center	Stony Brook	New York	United States	11794
51	University of North Carolina Heart and Vascular	Chapel Hill	North Carolina	United States	27599
52	Carolinas Healthcare (SHVI)-Clinical Research	Charlotte	North Carolina	United States	28203
53	Duke University Health System	Durham	North Carolina	United States	27710
54	Wake Forest Baptist Health	Winston-Salem	North Carolina	United States	27157
55	The Lindner Center for Research & Education at The Christ Hospital	Cincinnati	Ohio	United States	45219
56	University Hospitals Case Medical Center	Cleveland	Ohio	United States	44106
57	The MetroHealth System	Cleveland	Ohio	United States	44109
58	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
59	The Ohio State University	Columbus	Ohio	United States	43210
60	OhioHealth Research Institute	Columbus	Ohio	United States	43214-3907
61	Geisinger Medical Center	Danville	Pennsylvania	United States	17822
62	Lancaster General Hospital	Lancaster	Pennsylvania	United States	17604
63	Thomas Jefferson University Hospitals, Inc	Philadelphia	Pennsylvania	United States	19107
64	University of Pennsylvania Health System	Philadelphia	Pennsylvania	United States	19130
65	UPMC	Pittsburgh	Pennsylvania	United States	15213
66	Lankenau Medical Center	Wynnewood	Pennsylvania	United States	19096
67	Vascular Disease Research Center at Rhode Island Hospital	Providence	Rhode Island	United States	02903
68	Medical University of South Carolina	Charleston	South Carolina	United States	29425
69	Stern Cardiovascular Foundation, Inc.	Memphis	Tennessee	United States	38138
70	Vanderbilt Medical Center	Nashville	Tennessee	United States	37232-7235
71	Austin Heart PLLC / Heart Hospital of Austin	Austin	Texas	United States	78756
72	VA North Texas Health Care System	Dallas	Texas	United States	75216
73	Soltero Cardiovascular Research Center - Baylor Jack and Jane Hamilton Heart & Vascular Hospital	Dallas	Texas	United States	75226
74	The Methodist Hospital	Houston	Texas	United States	77030
75	The Heart Hospital Baylor Plano	Plano	Texas	United States	75093
76	Fletcher Allen Health Care	Burlington	Vermont	United States	05401
77	University of Virginia	Charlottesville	Virginia	United States	22908
78	Virginia Commonwealth University	Richmond	Virginia	United States	23298
79	Aurora St. Luke's Medical Center	Milwaukee	Wisconsin	United States	53215

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Medtronic Vascular

ClinicalTrials.gov Identifier:

NCT01418261

Other Study ID Numbers:

IP125

First Posted:

Aug 17, 2011

Last Update Posted:

Apr 26, 2017

Last Verified:

Apr 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Medtronic Vascular

uncontrolled hypertension

renal denervation

Additional relevant MeSH terms:

Hypertension

Study Results

No Results Posted as of Apr 26, 2017