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

Sponsor:	Medtronic Vascular
Information provided by (Responsible Party):	Medtronic Vascular
ClinicalTrials.gov Identifier:	NCT01418261

Purpose

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	Intervention	Phase
Uncontrolled Hypertension	Device: Renal denervation (Symplicity Catheter System)	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

U.S. FDA Resources

Further study details as provided by Medtronic Vascular:

Primary Outcome Measures:

Change in Office Systolic Blood Pressure [ Time Frame: Baseline to 6 months post-randomization ] [ Designated as safety issue: No ]
Primary Effectiveness Outcome Measure
Incidence of Major Adverse Events through 1 month post-randomization (Renal artery stenosis measured at 6 months) [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Change in average 24-hour Systolic Blood Pressure by ambulatory blood pressure monitoring [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	530
Study Start Date:	September 2011
Estimated Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Renal Denervation Subjects are treated with the renal denervation procedure after randomization and are maintained on baseline anti-hypertensive medications	Device: Renal denervation (Symplicity Catheter System) Symplicity Catheter System
No Intervention: Control group Subjects are maintained on baseline anti-hypertensive medications

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01418261

Contacts

Contact: V. DeBruin

RS.CT-GovInquiry@medtronic.com

Show 65 Study Locations

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

More Information

No publications provided

Responsible Party:	Medtronic Vascular
ClinicalTrials.gov Identifier:	NCT01418261 History of Changes
Other Study ID Numbers:	IP125
Study First Received:	August 15, 2011
Last Updated:	May 8, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Medtronic Vascular:

uncontrolled hypertension
renal denervation

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2012