Medtronic Begins SYMPLICITY HTN-4 Trial of Renal Denervation for Moderate Uncontrolled Hypertension

December 17, 2013—Medtronic, Inc. (Minneapolis, MN) announced that the first patients were randomized in the SYMPLICITY HTN-4 trial, which is evaluating the company’s Symplicity renal denervation system in patients with moderate uncontrolled hypertension (defined as systolic blood pressure ≥ 140 and < 160 mm Hg, despite treatment with three or more antihypertensive medications of different classes).

The first patients in SYMPLICITY HTN-4 were enrolled at Medical University of South Carolina in Charleston, South Carolina; Piedmont Heart Institute in Atlanta, Georgia; and Duke University Medical Center in Durham, North Carolina.

The principal investigators of SYMPLICITY HTN-4 are David Kandzari, MD, and Michael Weber, MD. Dr. Kandzari is Director and Chief Scientific Officer, Interventional Cardiology and Interventional Cardiology Research, at Piedmont Heart Institute. Dr. Weber is Professor of Medicine, Division of Cardiovascular Medicine, at the SUNY Downstate College of Medicine in Brooklyn, New York.  

According to Medtronic, SYMPLICITY HTN-4 will enroll up to 580 patients at approximately 100 sites. The study targets the population of patients with uncontrolled hypertension, as defined by the Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure; the American Heart Association; and the European Society of Hypertension.

The SYMPLICITY HTN-4 study will be blinded and include a sham control. This study design is similar to the design of SYMPLICITY HTN-3, the United States pivotal trial evaluating patients with uncontrolled hypertension with a systolic blood pressure ≥ 160 mm Hg. More information about SYMPLICITY HTN-4 is available online at www.symplifybptrial.com.

In the United States, the Symplicity renal denervation system is available for investigational use only, advised Medtronic.