May 9, 2012 (Tampa, FL) - Tampa General Hospital is offering an investigational treatment option for people who are now taking multiple medications to battle treatment-resistant hypertension, or high blood pressure. A clinical trial now underway will assess the safety and effectiveness of a new procedure that targets the nerves that regulate blood pressure.
Treatment-resistant hypertension is blood pressure that remains high (greater than 160/90 mmHg) despite treatment with three or more anti-hypertensive medications. The chronic condition poses a serious health threat to nearly six million Americans and 100 million people worldwide and is especially dangerous because of its association with increased cardiovascular risk, including stroke and heart attack, as well as heart failure and kidney disease.
“These are people who are unable to get their blood pressure under control despite treatment with three, four, five or six medications,” said Dr Fadi Matar, an interventional cardiologist at Tampa General. “Once the study is completed and if the device is approved by FDA, this novel approach to treatment resistant hypertension may finally help address this public health challenge.”
The trial focuses on the body’s sympathetic nervous system, nerves that connect the brain, the heart, the blood vessels, and kidneys – each of which helps regulate the body’s blood pressure.
When overactive, those nerves can raise blood pressure and contribute to heart, kidney and blood vessel damage.
The process is a minimally invasive, catheter-based procedure. A flexible catheter s inserted into the femoral artery in the upper thigh and is threaded up to the renal artery near each kidney. Once in place, an external generator delivers radiofrequency to modulate the surrounding sympathetic nerves. It does not involve a permanent implant.
This investigational system has been used since 2007 to treat more than 4,000 patients worldwide. It has been commercially available in Europe and Australia since April 2010. The Symplicity Renal Denervation System is not approved by the U.S. Food and Drug Administration (FDA) for commercial distribution in the United States. This device is limited by federal law to investigational use.
For more information about this clinical trial please contact the Office of Clinical Research at Tampa General at (813) 844-5458.