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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic Vascular
ClinicalTrials.gov Identifier:
NCT01418261
First received: August 15, 2011
Last updated: October 3, 2014
Last verified: October 2014

August 15, 2011
October 3, 2014
September 2011
December 2013   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01418261 on ClinicalTrials.gov Archive Site
Change in average 24-hour Systolic Blood Pressure by ambulatory blood pressure monitoring [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Renal Denervation in Patients With Uncontrolled Hypertension (SYMPLICITY HTN-3)
Not Provided

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Uncontrolled Hypertension
Device: Renal denervation (Symplicity Catheter System)
Symplicity Catheter System
  • Experimental: Renal Denervation
    Subjects are treated with the renal denervation procedure after randomization and are maintained on baseline anti-hypertensive medications
    Intervention: Device: Renal denervation (Symplicity Catheter System)
  • No Intervention: Control group
    Subjects are maintained on baseline anti-hypertensive medications
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
530
Not Provided
December 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01418261
IP125
Yes
Medtronic Vascular
Medtronic Vascular
Not Provided
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
Medtronic Vascular
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP