Medtronic, Inc., has kicked off its SYMPLICITY HTN-4 study with the news that the first patients have been randomized. The study, which started enrolling in November 2013 will evaluate the Symplicity™ renal denervation system in patients with moderate uncontrolled hypertension, despite treatment with three or more anti-hypertensive medications of different classes.
SYMPLICITY HTN-4 randomized its first patients at Medical University of South Carolina (MUSC), Piedmont Heart Institute and Duke University Medical Center. Medtronic says the new study builds upon SYMPLICITY HTN-3, the only other renal denervation clinical trial in the United States.
The study will enroll up to 580 patients with systolic blood pressures greater than or equal to 140 and less than 160 mm Hg 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 U.S. pivotal trial, SYMPLICITY HTN-3 study evaluating patients with uncontrolled hypertension with a systolic blood pressure greater than or equal to 160 mm Hg, the SYMPLICITY HTN-4 study will be blinded and include a sham control.
“SYMPLICITY HTN-4 demonstrates Medtronic’s commitment to providing randomized 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.
Source: Medtronic, Inc.