Medtronic has announced that the first patients were randomised in SYMPLICITY HTN-4, evaluating the Symplicity renal denervation system in patients with moderate uncontrolled hypertension (systolic blood pressure ≥140mmHg and <160mmHg, despite treatment with three or more antihypertensive medications of different classes).
SYMPLICITY HTN-4, which randomised its first patients at Medical University of South Carolina (MUSC), Piedmont Heart Institute and Duke University Medical Center, builds upon SYMPLICITY HTN-3, the only other renal denervation clinical trial in the United States. In the United States, the Symplicity renal denervation system is available for investigational use only.
“SYMPLICITY HTN-4 demonstrates Medtronic’s commitment to providing randomised safety and efficacy data for renal denervation in a wide variety of patients, as well as helping increase our understanding of the potential benefit of renal denervation for more patients with treatment resistant hypertension,” said Nina Goodheart, vice president, general manager, Renal Denervation, Medtronic.
SYMPLICITY HTN-4 will enrol up to 580 patients with systolic blood pressures ≥140mmHg and <160mmHg at approximately 100 sites, continuing to target a patient population in line with the Joint National Committee on the Prevention, Detection, Evaluation and Treatment of High Blood Pressure (JNC-7), the American Heart Association and the European Society of Hypertension’s definition of uncontrolled hypertension. Similar to the US pivotal trial, SYMPLICITY HTN-3 study evaluating patients with uncontrolled hypertension with a systolic blood pressure greater than or equal to 160mmHg, the SYMPLICITY HTN-4 study will be blinded and include a sham control.
The principal investigators of SYMPLICITY HTN-4 are David Kandzari, director and chief scientific officer, Interventional Cardiology and Interventional Cardiology Research, Piedmont Heart Institute, Atlanta, and Michael Weber, professor of medicine, Division of Cardiovascular Medicine, at the SUNY Downstate College of Medicine in Brooklyn, New York. For more information about SYMPLICITY HTN-4, please go to www.symplifybptrial.com.