Patients who struggle with controlling high blood pressure soon may have reason for hope, given a clinical trial studying an innovative denervation system.
The Medical University of South Carolina (MUSC) is the only medical center in South Carolina and the first site in the country to randomize a patient in the Symplicity HTN-4 clinical trial intended to treat uncontrolled hypertension.
The trial investigates the efficacy and safety of the investigational Symplicity renal denervation system in volunteers who have blood pressure between 140 and 160 mmHg and are unable to control their hypertension (high blood pressure) even when taking maximum tolerated doses of three or more blood pressure medications.
“We’re excited to participate in the Symplicity HTN-4 trial,” said Thomas M. Todoran, M.D., assistant professor of medicine, director of vascular medicine at MUSC. “This investigational interventional treatment represents an innovative approach to treating the growing number of patients with uncontrolled hypertension in the United States.
“Renal denervation, along with ongoing treatment with antihypertensive medications, has the potential to help patients achieve their target blood pressure levels.”
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.
Renal denervation is an investigational catheter-based procedure that deactivates the 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 body’s mechanisms for regulating blood pressure. In people with hypertension, renal nerves are typically hyperactive, raising blood pressure and contributing to heart, kidney and blood vessel damage.
| ||This radio frequency device provides energy near the nerves of the kidney to help lower a patient's blood pressure.|
The trial program will attempt to disrupt hyperactive nerves by applying brief radio frequency (RF) energy near those nerves with an experimental medical device that is inserted through a tube in the groin and placed in the artery leading to the kidney. Using RF, multiple treatments are performed in each artery to disrupt the hyperactive nerves. Following treatment, the device is removed.
The study will randomize more than patients in up to 100 U.S. medical centers. Patients in the clinical trial will be randomized to receive either renal denervation and anti-hypertensive medications or treatment with anti-hypertensive medications alone.
A randomized clinical trial is a study in which participants are assigned by chance to separate groups to compare different treatments; neither the researchers nor the participants can choose the group and participants do not know which group they’ve been assigned to or which treatment they are receiving. Using chance to assign people to groups allows the treatments they receive to be compared objectively. At the time of the trial, it is not known which treatment is best. A patient who has been randomized has been placed in their group for the trial. It is the patient's choice to participate in a randomized trial.