Medtronic has announced that it has received investigational device exemption (IDE) approval from the FDA to conduct SYMPLICITY HTN-4—the first randomised trial to investigate renal denervation for the treatment of moderate uncontrolled hypertension in US patients.
According to a press release, the SYMPLICITY HTN-4 study builds upon the SYMPLICITY HTN-3 study (Medtronic’s US clinical trial of the Symplicity renal denervation system, which is evaluating patients with uncontrolled hypertension). The new study will enrol up to 580 patients with systolic blood pressures greater than or equal to 140 and less than 160mmHg at approximately 100 sites. Similar to SYMPLICITY HTN-3, the study will be blinded and include a sham control. Efficacy will be evaluated based on the ability of subjects to either meet the goal of achieving a systolic blood pressure below 140mmHg or to achieve a pre-specified reduction in 24-hour ambulatory blood pressure. Safety will be assessed, as it is in SYMPLICITY HTN-3, by evaluating major adverse events at one-month and renal artery stenosis at six months.
“This highly-anticipated, robust study will serve a key role in evaluating renal denervation in these under-served patients with less severe hypertension so that we’re able to understand what benefit this novel therapy may offer patients outside of the currently indicated patient population,” said Michael Weber, co-Primary Investigator of SYMPLICITY HTN-4 and professor of Medicine, Division of Cardiovascular Medicine, at the SUNY Downstate College of Medicine in Brooklyn, USA.