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

Sponsor

Medtronic Vascular (Industry)

Overall Status

Completed

CT.gov ID

NCT01972139

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

14.7

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

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.

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	N/A

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

Study Type:

Interventional

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 :

Oct 1, 2013

Actual Primary Completion Date :

Jul 1, 2014

Actual Study Completion Date :

Jan 1, 2017

Arms and Interventions

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.	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.

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.

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

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Piedmont Hospital	Atlanta	Georgia	United States	30309
2	Duke University Medical Center	Durham	North Carolina	United States	27710
3	Medical University of South Carolina	Charleston	South Carolina	United States	29425