Hypertension Clinical Trial Focuses on Renal Connection
(July 16, 2012) The Ochsner Heart & Vascular Institute is now enrolling patients with treatment-resistant hypertension—systolic blood pressure that remains high (systolic pressure greater than 160 mmHg) despite treatment with 3 or more antihypertensive medications—in a new clinical trial. The SYMPLICITY HTN-3 study is designed to determine if renal denervation (interruption of nerve connections) is a safe and effective way to lower blood pressure in treatment-resistant patients. Ochsner is the only hospital in the state participating in this study.
People with hypertension have hyperactive renal nerves. The renal denervation treatment will attempt to disrupt this hyperactivity and regulate the output of nerves by applying brief radio frequency (RF) energy near the nerves with an experimental medical device.
During the procedure, a catheter is introduced into the femoral artery and then threaded into the renal artery leading to each kidney. The catheter is connected to the Symplicity® generator that produces the RF energy. The tip of the catheter is placed against the arterial wall in several places where it uses RF energy to deactivate the renal nerves according to a proprietary, computer-controlled algorithm. After treatment, the device is removed. No permanent implant is required, and the treatment is performed under conscious sedation.
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.
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. Those in the control group may receive the treatment after 6 months if their condition warrants it.
Contact Cristine Hardy, MS, CCRP at 504-842-6832 for more information about the SYMPLICITY HTN-3 study.