Renal Denervation in Patients With Uncontrolled Hypertension - SYMPLICITY 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: May 30, 2014
Last verified: May 2014

October 22, 2013
May 30, 2014
October 2013
August 2014   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01972139 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Renal Denervation in Patients With Uncontrolled Hypertension - SYMPLICITY HTN-4
Renal Denervation 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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Hypertension
  • Vascular Diseases
  • Cardiovascular Diseases
Device: Renal Denervation
Other Name: Symplicity Renal Denervation System
  • Experimental: Renal Denervation
    Subjects are treated with the renal denervation procedure after randomization and are maintained on baseline anti-hypertensive medications for at least 6 months.
    Intervention: Device: Renal Denervation
  • Sham Comparator: Control
    Subjects are maintained on baseline anti-hypertensive medications.
    Intervention: Device: Renal Denervation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
580
February 2017
August 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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01972139
HTN-4
Yes
Medtronic Vascular
Medtronic Vascular
Not Provided
Principal Investigator: David Kandzari, MD Piedmont Heart Institute
Principal Investigator: Michael Weber, MD SUNY Downstate College of Medicine
Medtronic Vascular
May 2014

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