Solomon and Dauerman Examine Novel High Blood Pressure Treatment
- By Mike Noble
The University of Vermont/Fletcher Allen Health Care is one of up to 90 sites in the United States selected to participate in a clinical trial to investigate a new procedure to care for patients with treatment-resistant high blood pressure. This condition occurs when systolic blood pressure – the force of blood in the arteries as the heart beats – remains high despite treatment with three or more high blood pressure medications. This disorder poses a serious health threat to nearly six million Americans.
The investigational procedure – called renal denervation – is a minimally-invasive, catheter-based procedure that modifies the output of nerves that lie within the renal artery wall and lead into and out of the kidneys. These nerves are part of the body’s sympathetic nervous system, which is known for the body’s “fight or flight” response and is one of the ways the body controls blood pressure. In people with high blood pressure, or hypertension, the renal nerves are hyperactive and raise blood pressure, contributing to heart, kidney and blood vessel damage.
The renal denervation procedure is performed in a cardiac catheterization laboratory. A catheter is inserted into patient’s femoral artery in the upper leg and moved up to the renal artery. Once in place within the renal artery, the tip of the catheter is placed against the arterial wall in several places where it uses controlled, low-power radio-frequency (RF) energy to modify the renal nerves according to a proprietary, computer-controlled procedure. The treatment does not involve a permanent implant and is performed under conscious sedation.
This trial uses a renal denervation system made by Medtronic, called Symplicity. The trial will determine the safety and efficacy of this new type of treatment. The team participating in this trial comprises staff from both UVM/Fletcher Allen’s cardiology and nephrology departments.
“We’re excited to participate in the study of this investigational interventional treatment, which may represent a new and innovative approach to treating the growing number of resistant hypertension patients in the United States,” said Harry Dauerman, M.D., UVM professor of medicine and director of the Cardiac Catheterization Laboratory at Fletcher Allen. “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.”
People considering participation in the trial should be diagnosed with hypertension (high blood pressure) and unable to control their hypertension even when taking three or more blood pressure medications. Learn more about the trial at Fletcher Allen or contact Richard Solomon, M.D., UVM/Fletcher Allen professor of medicine and chief of nephrology at 802-847-3572. General trial information and eligibility requirements are available on the Medtronic SYMPLICITY HTN-3 U.S. Clinical Trial website.
About the Medtronic Symplicity Renal Denervation System
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 energy. The Symplicity renal denervation system has been successfully used since 2007 to treat more than 2000 patients worldwide. It has been commercially available in Europe and Australia since April 2010. The Symplicity renal denervation system is not approved by the US Food and Drug Administration (FDA) for commercial distribution in the USA.