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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.
 
ClinicalTrials.gov Identifier: NCT01972139
Recruitment Status : Completed
First Posted : October 30, 2013
Last Update Posted : April 26, 2017
Sponsor:
Information provided by (Responsible Party):
Medtronic Vascular

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypertension Vascular Diseases Cardiovascular Diseases Device: Renal Denervation using the Symplicity Renal Denervation System Other: Sham Renal Denervation Device: Renal Angiography Not Applicable

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Renal Denervation Using the SYMPLICITY Renal Denervation System in Patients With Uncontrolled Hypertension - SYMPLICITY HTN-4
Study Start Date : October 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Renal Denervation
Subjects are treated with the renal denervation procedure after randomization.
 Device: Renal Denervation using the Symplicity Renal Denervation System
Subjects randomized to the renal denervation group underwent angiography and renal denervation.

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.
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
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.


Outcome Measures
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Primary Outcome Measures :
  1. Reaching BP Goal [ Time Frame: 6 months post-randomization ]
  2. Incidence of Major Adverse Events through 1 month post-procedure (Renal artery stenosis measured at 6 months) [ Time Frame: Baseline to 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01972139


Locations
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United States, Georgia
Piedmont Hospital
Atlanta, Georgia, United States, 30309
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medtronic Vascular
Investigators
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Principal Investigator: David Kandzari, MD Piedmont Heart Institute
Principal Investigator: Michael Weber, MD SUNY Downstate College of Medicine
More Information
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Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT01972139    
Other Study ID Numbers: HTN-4
First Posted: October 30, 2013    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017
Keywords provided by Medtronic Vascular:
Uncontrolled hypertension
blood pressure
renal denervation
HTN-4
SYMPLICITY
Additional relevant MeSH terms:
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Hypertension
Cardiovascular Diseases
Vascular Diseases