NCT01972139

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Oct 2013

Typical duration for not_applicable hypertension

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

October 22, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 30, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

April 26, 2017

Status Verified

April 1, 2017

Enrollment Period

9 months

First QC Date

October 22, 2013

Last Update Submit

April 24, 2017

Conditions

HypertensionVascular DiseasesCardiovascular Diseases

Keywords

Uncontrolled hypertensionblood pressurerenal denervationHTN-4SYMPLICITY

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Renal Denervation

EXPERIMENTAL

Subjects are treated with the renal denervation procedure after randomization.

Device: Renal Denervation using the Symplicity Renal Denervation SystemDevice: Renal Angiography

Control

OTHER

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 DenervationDevice: Renal Angiography

Interventions

Renal Denervation using the Symplicity Renal Denervation SystemDEVICE

Subjects randomized to the renal denervation group underwent angiography and renal denervation.

Renal Denervation
Sham Renal DenervationOTHER

Prior to enrollment closure, subjects were treated with sham renal denervation. After enrollment closure, subjects previously enrolled were no longer eligible to cross-over.

Control
Renal AngiographyDEVICE

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.

ControlRenal Denervation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Piedmont Hospital

Atlanta, Georgia, 30309, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

HypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • David Kandzari, MD

    Piedmont Heart Institute

    PRINCIPAL INVESTIGATOR

  • Michael Weber, MD

    SUNY Downstate College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2013

First Posted

October 30, 2013

Study Start

October 1, 2013

Primary Completion

July 1, 2014

Study Completion

January 1, 2017

Last Updated

April 26, 2017

Record last verified: 2017-04

Locations

US(3)