January 22, 2014

The CAMC Clinical Trials Center will be participating in the SYMPLICITY HTN- 4 renal denervation clinical trial for uncontrolled hypertention, otherwise known as high blood pressure. The trial will be led at CAMC by Drs. Aravinda Nanjundappa, Mark Bates, John Campbell and James Campbell.

Uncontrolled high blood pressure, defined by the American Heart Association as blood pressure >140/90 mmHg, poses a serious health threat to more than 40 million Americans. High blood pressure is an especially dangerous chronic disease because of its association with increased cardiovascular risk, including stroke and heart attack, as well as other disease states such as heart failure and kidney disease. Reduction of high blood pressure and control of hypertention has been shown to reduce the incidence of these cardiovascular events and save lives.

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 ways the body controls blood pressure. In people with hypertention, the renal nerves could be hyperactive, raising blood pressure and contributing to heart, kidney and blood vessel damage.

This investigational interventional treatment, may represent an innovative approach to treating the growing number of patients with uncontrolled high blood pressure in the United States. Renal denervation and ongoing treatment with antihypertensive medications have the potential to help patients achieve their target blood pressure levels.

SYMPLICITY HTN-4 is a randomized, controlled trial designed to evaluate the efficacy and safety of renal denervation with the investigational Symplicity renal denervation system in patients with uncontrolled high blood pressure and systolic blood pressure 140−<160 mmHg on at least three antihypertensive medications.

The trial will randomize approximately 530 patients across several U.S. medical centers. People receiving the investigational treatment will be compared with a control group that will not receive the investigational treatment, with all patients continuing to take their blood pressure medications.

Patients enrolled in the SYMPLICITY HTN-4 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. The primary efficacy endpoint of the trial is reaching an office systolic blood pressure with at least a 5-mmHg reduction or achieving a 5-mmHg reduction in 24-hour ambulatory blood pressure six months post-randomization.

This trial has a design that may be beneficial for all patients in the trial since those 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 the procedure if the trial demonstrates benefit.

The Symplicity® renal denervation system consists of a flexible catheter and proprietary generator. The catheter is introduced into the renal artery leading to each kidney. It is connected to the Symplicity® generator, which produces controlled, low-power radiofrequency energy. The tip of the Symplicity® catheter is placed against the arterial wall in several places to deactivate the renal nerves. The treatment does not involve a permanent implant and is performed under conscious sedation.

The Symplicity® renal denervation system has been used since 2007 to treat nearly 5,000 patients worldwide and is commercially available in Europe, Asia, Africa, Australia and the Americas. The Symplicity® renal denervation system is not approved by the U.S. Food and Drug Administration for commercial distribution in the United States.

The CAMC Clinical Trials Center can be reached at (304) 388-9944.

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