Overview

This trial is active, not recruiting.

Conditions hypertension, vascular diseases, cardiovascular diseases
Treatments renal denervation using the symplicity renal denervation system, sham renal denervation, renal angiography
Phase phase 3
Sponsor Medtronic Vascular
Start date October 2013
End date July 2014
Trial size 44 participants
Trial identifier NCT01972139, HTN-4

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
Subjects are treated with the renal denervation procedure after randomization.
renal denervation using the symplicity renal denervation system
Subjects randomized to the renal denervation group underwent angiography and renal denervation.
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)
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.
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.
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.

Primary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title Renal Denervation Using the SYMPLICITY Renal Denervation System in Patients With Uncontrolled Hypertension - SYMPLICITY HTN-4
Principal investigator David Kandzari, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Medtronic Vascular.