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

N/ACompletedNCT01972139

Medtronic Vascular44 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Hypertension Vascular Diseases Cardiovascular Diseases

Interventions

Renal Denervation using the Symplicity Renal Denervation SystemDEVICE

Subjects randomized to the renal denervation group underwent angiography and 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.

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (3)

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

Outcomes

Primary Outcomes

Reaching BP Goal

Time frame: 6 months post-randomization

Incidence of Major Adverse Events through 1 month post-procedure (Renal artery stenosis measured at 6 months)

Time frame: Baseline to 6 months

Data from ClinicalTrials.gov

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