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

NCT ID: NCT01972139

Last Updated: 2017-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2017-01-31

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.

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.

Conditions

Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Renal Denervation

Subjects are treated with the renal denervation procedure after randomization.

Group Type: EXPERIMENTAL

Renal Denervation using the Symplicity Renal Denervation System

Intervention Type: DEVICE

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

Renal Angiography

Intervention Type: DEVICE

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.

Group Type: OTHER

Sham Renal Denervation

Intervention Type: OTHER

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

Renal Angiography

Intervention Type: DEVICE

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.

Interventions

Renal Denervation using the Symplicity Renal Denervation System

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

Intervention Type: DEVICE

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.

Intervention Type: OTHER

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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Vascular

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Kandzari, MD

Role: PRINCIPAL_INVESTIGATOR

Piedmont Heart Institute

Michael Weber, MD

Role: PRINCIPAL_INVESTIGATOR

SUNY Downstate College of Medicine

Locations

Piedmont Hospital

Atlanta, Georgia, United States

Duke University Medical Center

Durham, North Carolina, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Other Identifiers

HTN-4

Identifier Type: -

Identifier Source: org_study_id