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

This study is currently recruiting participants.
Verified May 2013 by Medtronic Vascular
Sponsor:
Information provided by (Responsible Party):
Medtronic Vascular
ClinicalTrials.gov Identifier:
NCT01418261
First received: August 15, 2011
Last updated: May 2, 2013
Last verified: May 2013
History of Changes
  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:

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: June 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 88 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 2, 2013
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 21, 2013