Renal Denervation in Patients With Uncontrolled Hypertension - SYMPLICITY HTN-4 (HTN-4)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01972139
Recruitment Status : Completed
First Posted : October 30, 2013
Last Update Posted : April 26, 2017
Information provided by (Responsible Party):
Medtronic Vascular

October 22, 2013
October 30, 2013
April 26, 2017
October 2013
July 2014   (Final data collection date for primary outcome measure)
  • Reaching BP Goal [ Time Frame: 6 months post-randomization ]
  • Incidence of Major Adverse Events through 1 month post-procedure (Renal artery stenosis measured at 6 months) [ Time Frame: Baseline to 6 months ]
Same as current
Complete list of historical versions of study NCT01972139 on Archive Site
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Renal Denervation in Patients With Uncontrolled Hypertension - SYMPLICITY HTN-4
Renal Denervation Using the SYMPLICITY Renal Denervation System in Patients With Uncontrolled Hypertension - SYMPLICITY HTN-4
An international, multi-center, prospective, blinded, randomized, controlled trial. The objective is to demonstrate that catheter-based renal denervation is an effective and safe treatment for uncontrolled hypertension.
After the 6 month follow-up required testing has been completed, control group subjects would be unblinded to their randomization group and would have an option, at the discretion of the Investigator and with written concurrence of the medical monitor, to be treated with renal denervation procedure. However, after enrollment closure, subjects previously randomized were no longer allowed to cross-over.
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
  • Hypertension
  • Vascular Diseases
  • Cardiovascular Diseases
  • Device: Renal Denervation using the Symplicity Renal Denervation System
    Subjects randomized to the renal denervation group underwent angiography and renal denervation.
  • Other: Sham Renal Denervation
    Prior to enrollment closure, subjects were treated with sham renal denervation. After enrollment closure, subjects previously enrolled were no longer eligible to cross-over.
  • Device: Renal Angiography
    Subjects who met all criteria after the screening period did undergo a renal artery angiogram to evaluate renal artery anatomy. Only subjects with eligible renal artery anatomy were randomized.
  • Experimental: Renal Denervation
    Subjects are treated with the renal denervation procedure after randomization.
    • Device: Renal Denervation using the Symplicity Renal Denervation System
    • Device: Renal Angiography
  • Control
    Subjects randomized prior to enrollment closure were treated with sham renal denervation (angiography only). Once enrollment was closed and the protocol revised, no control subjects crossed-over.
    • Other: Sham Renal Denervation
    • Device: Renal Angiography
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
January 2017
July 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Individual is on maximally tolerated stable medication regimen including 3 or more anti-hypertensive medications of different classes, one of which must be a thiazide or thiazide-like diuretic
  • Individual has office SBP greater than or equal to 140mmHg and less than 160mmHg
  • Individual has ABPM average SBP greater than or equal to 135 mmHg

Exclusion Criteria:

  • Individual lacks appropriate renal artery anatomy
  • Individual has eGFR of less than 30
  • Individual has Type I diabetes mellitus
  • Individual has had one or more episodes of orthostatic hypotension
  • Individual requires chronic oxygen other than nocturnal respiratory support for sleep apnea
  • Individual has primary pulmonary hypertension
  • Individual has other concomitant conditions that may adversely affect the patient or the study outcomes
  • Individual is pregnant, nursing or planning to be pregnant
  • Individual has had a previous organ transplant
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Medtronic Vascular
Medtronic Vascular
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Principal Investigator: David Kandzari, MD Piedmont Heart Institute
Principal Investigator: Michael Weber, MD SUNY Downstate College of Medicine
Medtronic Vascular
April 2017

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