Thomas Jefferson University Hospital Participates in Major Study to Treat Challenging Hypertension
February 05, 2013
Uncontrolled or treatment-resistant hypertension poses a serious health threat to nearly six million Americans and 100 million people worldwide.
Patients between the ages of 18 and 80 who have medication-resistant hypertension, defined as a blood pressure greater than 160/90 despite treatment with three or more antihypertensive medications, are needed for a new clinical trial at Thomas Jefferson University Hospital. The trial will evaluate renal denervation as an investigational approach to treating treatment-resistant hypertension, a deactivation of the nerves that line the walls of the arteries leading to the kidneys. The renal 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 can be hyperactive, raising blood pressure and contributing to heart, kidney and blood vessel damage. Renal denervation is an investigational catheter-based procedure.
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 medication-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.
“We’re excited to participate in this trial evaluating this investigational interventional therapy, which may represent a new and innovative approach to treating the growing number of treatment-resistant hypertension patients in the United States,” says Nicholas J. Ruggiero II, MD, Director of Structural Heart Disease and Non-Coronary Interventions and principal investigator for the study at Jefferson. “Renal denervation and ongoing treatment with antihypertensive medications have the potential to help patients with this challenging form of hypertension achieve their target blood pressure levels.”
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.
“This study has a unique design since patients in the control group may have the option to receive renal denervation treatment six months following randomization if they continue to meet eligibility criteria, which may help extend the potential benefit of renal denervation to all participants in the trial if the trial demonstrates benefit,” says Dr. Ruggerio.
Patients can contact Lisha Anthony, research nurse at 215-503-5521 for more information about the clinical trial at Jefferson. Prospective participants also are encouraged to visit www.SymplifyBPtrial.com to learn more about the SYMPLICITY HTN-3 study and their potential eligibility for the trial. People considering participation in the trial should be diagnosed with hypertension (high blood pressure) and unable to control their hypertension even when taking maximum-tolerated doses of three or more blood pressure medications.