St. Joseph Hospital initiates enrollment in Medtronic’s SYMPLICITY HTN-3 trial for hypertension

St. Joseph Hospital of Orange on July 11 enrolled its first patient as part of a national clinical trial conducted by Medtronic Inc. for a renal denervation procedure designed to eliminate treatment-resistant hypertension. St. Joseph Hospital is the only medical center in the Los Angeles/Orange County metro area conducting the clinical trial and is one of only four hospitals statewide conducting the study.    

Approximately 76 million Americans suffer from hypertension and about 9 million get no relief from available medicines. High blood pressure and chronic hypertension can lead to heart failure, heart disease, stroke and chronic kidney disease. Treatment-resistant hypertension is defined as systolic blood pressure that remains high (greater than 140/90 mmHg) despite treatment with three or more antihypertensive medications.

The renal denervation procedure is a minimally invasive, catheter-based method for regulating the output of nerves that line the walls of the arteries leading to the kidneys. These nerves are part of the sympathetic nervous system, which is one of the ways the body controls blood pressure. In people with hypertension, the renal nerves are hyperactive, raising blood pressure and contributing to heart, kidney and blood vessel damage.

The renal denervation technology has shown to reduce blood pressure by about 30 points in patients with resistant HTN (those who cannot be controlled by medication alone). Now this technology is available to those suffering from this devastating affliction, appropriately known as the "quiet killer."

"This is one of the most anticipated clinical trials in years addressing an important public health issue," said interventional radiologist Mahmood K. Razavi M.D., of St. Joseph Hospital who is an investigator on this study. "We enrolled our first patient in the clinical trial on Wednesday when we conducted a procedure in our Interventional Radiology suite. We are the only center in the region and one of only a handful in California who can perform this procedure for patients with resistant hypertension."

The clinical trial is being conducted by Medtronic with its SYMPLICITY HTN-3, which is a randomized, controlled trial designed to evaluate the safety and effectiveness of renal denervation with the investigational Symplicity renal denervation system in patients with treatment-resistant hypertension and systolic blood pressure higher than 160 mmHg. Medtronic has enrolled about 80 patients nationally so far with the goal of entering 530 treatment-resistant hypertension patients across several U.S. medical centers during the next year.

People receiving the investigational treatment will be compared with a control group that does not, with all patients continuing to take their blood pressure medications. Patients enrolled in the SYMPLICITY HTN-3 trial will be randomly assigned to a group, with two out of three assigned to the treatment group and one out of three assigned to the control group. In addition, those in the control group may receive the treatment after a six-month period passes. The primary endpoints of the study are the change in blood pressure from baseline to six months and incidence of major adverse events.