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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic Vascular
ClinicalTrials.gov Identifier:
NCT01972139
First received: October 22, 2013
Last updated: April 14, 2016
Last verified: April 2016
  Purpose
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 Intervention Phase
Hypertension
Vascular Diseases
Cardiovascular Diseases
Device: Renal Denervation
Other: Sham Renal Denervation
Device: Renal Angiography
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
Official Title: Renal Denervation in Patients With Uncontrolled Hypertension - SYMPLICITY HTN-4

Resource links provided by NLM:


Further study details as provided by Medtronic Vascular:

Primary Outcome Measures:
  • Reaching BP Goal [ Time Frame: 6 months post-randomization ] [ Designated as safety issue: No ]
  • Incidence of Major Adverse Events through 1 month post-procedure (Renal artery stenosis measured at 6 months) [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 44
Study Start Date: October 2013
Estimated Study Completion Date: February 2017
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Renal Denervation
Subjects are treated with the renal denervation procedure after randomization.
Device: Renal Denervation
Subjects randomized to the renal denervation group underwent angiography and renal denervation.
Other Name: Symplicity Renal Denervation System
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01972139

Locations
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
Principal Investigator: David Kandzari, MD Piedmont Heart Institute
Principal Investigator: Michael Weber, MD SUNY Downstate College of Medicine
  More Information

Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT01972139     History of Changes
Other Study ID Numbers: HTN-4 
Study First Received: October 22, 2013
Last Updated: April 14, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Medtronic Vascular:
Uncontrolled hypertension
blood pressure
renal denervation
HTN-4
SYMPLICITY

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 21, 2016