Hypertension Clinical Trial

Hypertension is endemic in the United States. The American Heart Association estimates that 76 million people, or one-third of adults, have high blood pressure. Of those adhering to multi-drug treatment regimens, an estimated 2% to 10% of patients still have severely elevated blood pressure of 160/90 mm Hg or greater. These patients are at double the risk for developing complications of hypertension, including heart attacks, heart failure and stroke. University of Maryland professor of medicine Elijah Saunders, M.D., points out, "… for African Americans, who tend to have a more severe form of hypertension, these risks are much greater, compared to their Caucasian counterparts."

The University of Maryland Medical Center is the only site in the state enrolling in Symplicity HTN-3. This is a randomized, single-blind, placebo-controlled clinical trial examining the safety and effectiveness of renal denervation for patients with treatment-resistant hypertension and a systolic blood pressure greater than 160 mm Hg. In phase 1 and phase 2 trials of this treatment strategy, average systolic blood pressure reductions of 30 mm Hg were achieved without evidence of renal complications.

“There are few options for treatment-resistant hypertension. For those patients who can’t control their blood pressure, despite being on three or more hypertension medicines at maximum doses, this clinical trial has potential for changing the way we manage one of the most common medical conditions,” explains the trial’s principal investigator, Anuj Gupta, M.D., an assistant professor of medicine at the University of Maryland School of Medicine.

Patients who meet criteria for the study undergo renal denervation using the Symplicity Catheter System, a product of Medtronic. A catheter is placed through the groin and positioned at multiple locations within the kidney’s arteries. Radiofrequency energy is then delivered to interrupt the sympathetic nerves supplying the kidneys. Patients stay in the hospital overnight. They then have follow-up visits at one, three and six months and then additional visits every six months.