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

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Intervention / Treatment: Device: Renal Denervation using the Symplicity Renal Denervation System; Device: Renal Angiography; Other: Sham Renal Denervation

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 Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Piedmont Hospital
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.
Other: 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.	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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Reaching BP Goal	6 months post-randomization
Incidence of Major Adverse Events through 1 month post-procedure (Renal artery stenosis measured at 6 months)	Baseline to 6 months

Collaborators and Investigators

• Sponsor: Medtronic Vascular
• Investigators: Principal Investigator: Michael Weber, MD, SUNY Downstate College of Medicine

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: October 22, 2013
• First Submitted That Met QC Criteria: October 24, 2013
• First Posted (Estimate): October 30, 2013

Study Record Updates

• Last Update Posted (Actual): April 26, 2017
• Last Update Submitted That Met QC Criteria: April 24, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: blood pressure; renal denervation; Uncontrolled hypertension; HTN-4; SYMPLICITY
• Additional Relevant MeSH Terms: Hypertension; Cardiovascular Diseases; Vascular Diseases
• Other Study ID Numbers: HTN-4

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No