search
Back to results

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

Primary Purpose

Hypertension, Vascular Diseases, Cardiovascular Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Renal Denervation using the Symplicity Renal Denervation System
Sham Renal Denervation
Renal Angiography
Sponsored by
Medtronic Vascular
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Uncontrolled hypertension, blood pressure, renal denervation, HTN-4, SYMPLICITY

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Piedmont Hospital
  • Duke University Medical Center
  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Renal Denervation

Control

Arm Description

Subjects are treated with the renal denervation procedure after randomization.

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.

Outcomes

Primary Outcome Measures

Reaching BP Goal
Incidence of Major Adverse Events through 1 month post-procedure (Renal artery stenosis measured at 6 months)

Secondary Outcome Measures

Full Information

First Posted
October 22, 2013
Last Updated
April 24, 2017
Sponsor
Medtronic Vascular
search

1. Study Identification

Unique Protocol Identification Number
NCT01972139
Brief Title
Renal Denervation in Patients With Uncontrolled Hypertension - SYMPLICITY HTN-4
Acronym
HTN-4
Official Title
Renal Denervation Using the SYMPLICITY Renal Denervation System in Patients With Uncontrolled Hypertension - SYMPLICITY HTN-4
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Vascular

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Vascular Diseases, Cardiovascular Diseases
Keywords
Uncontrolled hypertension, blood pressure, renal denervation, HTN-4, SYMPLICITY

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Renal Denervation
Arm Type
Experimental
Arm Description
Subjects are treated with the renal denervation procedure after randomization.
Arm Title
Control
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Renal Denervation using the Symplicity Renal Denervation System
Intervention Description
Subjects randomized to the renal denervation group underwent angiography and renal denervation.
Intervention Type
Other
Intervention Name(s)
Sham Renal Denervation
Intervention Description
Prior to enrollment closure, subjects were treated with sham renal denervation. After enrollment closure, subjects previously enrolled were no longer eligible to cross-over.
Intervention Type
Device
Intervention Name(s)
Renal Angiography
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reaching BP Goal
Time Frame
6 months post-randomization
Title
Incidence of Major Adverse Events through 1 month post-procedure (Renal artery stenosis measured at 6 months)
Time Frame
Baseline to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Kandzari, MD
Organizational Affiliation
Piedmont Heart Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Weber, MD
Organizational Affiliation
SUNY Downstate College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Piedmont Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs