Scripps Health is now enrolling patients in a clinical trial of an investigational treatment that shows promise to control high blood pressure by calming hyperactive nerves. The procedure, called renal denervation, could potentially help the nearly 6 million Americans and 100 million people worldwide that suffer from treatment-resistant hypertension.
Renal denervation is a minimally invasive procedure in which a physician threads a catheter into the arteries leading to the kidney, then delivers pulses of radio-frequency energy that interrupt the signaling in nerves to and from that organ. 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.
“We’re excited to participate this investigational interventional treatment, which may represent a new and innovative approach to treating the growing number of resistant hypertension patients in the U.S.,” said Dr. Paul Teirstein, study investigator and director of interventional cardiology at Scripps Clinic. “Renal denervation and ongoing treatment with anti-hypertensive medications has the potential to help patients with this challenging form of hypertension achieve their target blood pressure levels.”
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 risk of cardiovascular events compared to individuals with controlled high blood pressure.
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 U.S. medical centers. People receiving the investigational treatment will be compared to 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.
“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, which may help extend the potential benefit of renal denervation to all participants in the trial if the trial demonstrates benefit,” said Dr. Andrew King, a Scripps nephrologist and study investigator.
How the Symplicity Renal Denervation System works
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.
Patients can contact Chelsea Butler at Scripps Clinic at 858-554-5374 for more information about the clinical trial. 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 and unable to control their hypertension even when taking three or more blood pressure medications.
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