First Patient Enrolled in National Study for High Blood Pressure 04/19/2012 St. Joseph Mercy Ann Arbor Enrolls First Patient in Landmark Study to Evaluate Investigational Treatment for Challenging Hypertension
St. Joseph Mercy Ann Arbor has enrolled its first patient into a national clinical trial evaluating a novel procedure for difficult-to-treat high blood pressure (also called treatment-resistant hypertension). The study, SYMPLICITY HTN-3, is a landmark clinical trial evaluating the investigational Symplicity® renal denervation system.
Treatment-resistant hypertension, defined as high blood pressure despite treatment with three or more blood pressure lowering medications, poses a serious health threat to nearly nine million Americans.
Treatment-resistant hypertension is an especially dangerous chronic disease because of its association with increased risk for stroke, heart attack, heart failure and kidney disease. Research suggests that as many as 28 percent of treated individuals with high blood pressure are considered resistant to treatment. Additionally, these patients have a threefold increase in the risk of cardiovascular events compared with individuals with controlled high blood pressure.
Renal denervation is a minimally invasive, catheter-based procedure that delivers radiofrequency energy to interfere with the nerves that line the walls of the kidney arteries. These nerves are part of the sympathetic nervous system, and in people with high blood pressure (hypertension), the renal nerves are hyperactive, raising blood pressure and contributing to heart, kidney and blood vessel damage.
“We are thrilled to participate in the SYMPLICITY HTN-3 study of renal denervation. SYMPLICITY HTN-3 is evaluating an innovative approach to treating the growing population of people with resistant hypertension in the United States,” said Herbert D. Aronow, MD, MPH site principal investigator for the study. “The addition of renal denervation to ongoing treatment with blood pressure medications has the potential to help patients with this challenging form of hypertension achieve their target blood pressure levels.”
In all, the study plans to enroll approximately 530 treatment-resistant hypertension patients across 90 U.S. medical centers. People receiving the investigational treatment will be compared with a control group that undergoes a sham or 'fake' procedure while under sedation, 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. The primary endpoints of the study are the change in blood pressure from baseline to six months and incidence of major adverse events.
The St. Joseph Mercy Ann Arbor patient who is part of the trial passed all necessary preliminary evaluations in order to participate in the trial. Because this is a blinded trial, the hospital and its investigator cannot discuss whether the patient underwent a sham procedure or the renal sympathetic denervation procedure.
“The patient did extremely well and was excited to be a part of this groundbreaking study. The patient hopes the results will not only be life changing for them, but also offer progress toward better treatment for others who suffer from treatment-resistant hypertension,” commented Aronow. “We intend to enroll many more patients in this study as we collectively search for new treatment paradigms for patients suffering from severe hypertension.”
St. Joseph Mercy Ann Arbor is actively recruiting patients for the trial. Those interested in more information call 734-712-7602.
About the Symplicity Renal Denervation System
The Symplicity renal denervation system consists of a flexible catheter and proprietary generator. The Symplicity® catheter is introduced through a separate catheter placed through the skin into the femoral artery, located in the upper thigh, and is then threaded up into the renal artery leading to each kidney. It is connected to the Symplicity® generator, which produces controlled, low-power radio-frequency (RF) energy.
Once in place within the renal artery, the tip of the Symplicity catheter is placed against the arterial wall in several places where it uses controlled, low-power RF energy to deactivate the renal nerves according to a proprietary, computer-controlled algorithm. The treatment does not involve a permanent implant and is performed under conscious sedation.
The Symplicity renal denervation system has been successfully used since 2007 to treat more than 2000 patients worldwide. It has been commercially available in Europe and Australia since April 2010. The Symplicity renal denervation system is not approved by the US Food and Drug Administration (FDA) for commercial distribution in the USA.
More information about HTN-3 can be found at www.symplifybptrial.com.