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Completed

NCT Number: NCT01972139

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Piedmont Hospital, Atlanta, Georgia, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Renal Denervation using the Symplicity Renal Denervation System

Device

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

Sham Renal Denervation

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

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.

Primary outcomes

  1. Reaching BP Goal

    Time frame: 6 months post-randomization

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

    Time frame: Baseline to 6 months

Sponsors and collaborators

Lead sponsor

Medtronic Vascular

Industry

Registry information

Official study title

Renal Denervation Using the SYMPLICITY Renal Denervation System in Patients With Uncontrolled Hypertension - SYMPLICITY HTN-4

Acronym: HTN-4

Important dates

Study start
2013
Primary completion
2014
Study completion
2017
First posted
Oct 30, 2013
Registry last updated
Apr 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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