For Immediate Release
Apr 20, 2012
Contact : Maureen Gillespie, Manager, Public Relations
Simpler Solution to Hypertension is on the Horizon
Jersey Shore University Medical Center participates in Symplicity® trial – a landmark study to treat hypertension
Neptune, NJ -
Jersey Shore University Medical Center proudly announces that it is enrolling patients in the SYMPLICITY HTN-3 study, a clinical trial of the investigational Symplicity® renal denervation system for treatment-resistant hypertension. Treatment-resistant hypertension, systolic blood pressure that remains high despite treatment with three or more antihypertensive medications, is a serious health threat that affects nearly six million Americans and 100 million people worldwide.
Treatment-resistant hypertension is an especially dangerous chronic disease because of its association with increased cardiovascular risk, including stroke and heart attack, as well as heart failure and kidney disease. Research suggests that 28 percent of treated hypertensive individuals 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.
“Symplicity may represent a completely new approach towards the treatment of resistant hypertension. Through this innovation, a simple catheter procedure could replace a lifetime of hypertension medication, dramatically changing the way we treat patients with the most challenging forms of hypertension. It’s a new way to achieve target blood pressure levels and ultimately improve patients’ overall health,” says Ziad Abbud, M.D., FACC, Interventional Cardiologist & Principal Investigator, Jersey Shore University Medical Center & Clinical Assistant Professor, UMDNJ, Robert Wood Johnson Medical School.
Renal denervation is a minimally invasive, catheter-based procedure that regulates 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 Symplicity renal denervation system consists of a flexible catheter and proprietary generator. The treatment does not involve a permanent implant and is performed under conscious sedation.
“Symplicity has the potential to be a real game changer in the treatment of hypertension. Our hope is for Symplicity to do for hypertension what Lasik has done for poor vision. As one of only three hospitals in New Jersey chosen to conduct the trial, our participation reflects Jersey Shore’s position as a leading center for clinical research and our commitment to medical advances,” comments Dawn Calderon, D.O., Acting Chief, Cardiology & Medical Director, Cardiovascular Research at Jersey Shore University Medical Center.
About SYMPLICITY HTN-3 Trial - SYMPLICITY HTN-3 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. The study will enroll approximately 530 treatment-resistant hypertension patients across several US medical centers. 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. The Symplicity renal denervation systemhas 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 systemis not approved by the US Food and Drug Administration (FDA) for commercial distribution in the USA. Patients can contact Linda Murphy at Jersey Shore University Medical Center at 732.776.4796, or Dr. Ziad Abbud’s office at 732.663.1123 for more information about the clinical trial. People considering participation in the trial should be diagnosed with hypertension (high blood pressure) and unable to control their hypertension even when taking three or more blood pressure medications.
About Jersey Shore University Medical Center:
Jersey Shore University Medical Center, a member of the Meridian Health family, is a not-for-profit teaching hospital and home to K. Hovnanian Children’s Hospital – the first children’s hospital in Monmouth and Ocean counties. Jersey Shore is the regional provider of cardiac surgery, a program which has been ranked among the best in the Northeast, and is home to the only trauma center and stroke rescue center in the region. Jersey Shore University Medical Center specializes in cardiovascular care, orthopedics and rehabilitation, cancer care, neuroscience, and women’s specialty services. For more information on Jersey Shore University Medical Center call 1-800-DOCTORS, or visit www.JerseyShoreUniversityMedicalCenter.com.