The Emory Heart & Vascular Center is among 17 institutions worldwide evaluating an innovative approach to help lower high blood pressure without the use of medication.
Emory researchers are participating in the SPYRAL HTN Global Clinical Trial Program which includes two parallel trials - SPYRAL HTN-ON MED and SPYRAL HTN-OFF MED - each using a minimally invasive technique called renal denervation.
Overactive nerve signals to the kidneys can make it difficult to control high blood pressure. A renal denervation procedure uses radiofrequency (RF) energy to quiet this overactive nerve signaling in qualified hypertensive patients.
"We've known for decades that there is a link between sympathetic nerves, blood pressure and the kidneys, which are responsible for regulating the body's water and salt balance," says Emory Healthcare cardiologist Chandan Devireddy, MD, associate professor of medicine, Emory University School of Medicine.
The two multi-center, prospective randomized trials are designed to evaluate the effectiveness of Medtronic, Inc.'s Symplicity Spyral catheter compared with a sham procedure.
During the actual procedure, the catheter is advanced through a minimal puncture in a groin artery and then threaded into the kidney arteries. Once there, the catheter delivers low-power RF energy to heat nerves in the walls of the artery with the goal of reducing the impact these nerves play in raising blood pressure. The technique, called ablation, is similar to one commonly used by doctors to stabilize irregular heartbeats.
According to Devireddy, SPYRAL's minimally invasive approach to deactivate these overperforming nerves from the inside of the kidney arteries has been made possible by matching technical advances of the 21st century with well described physiologic principles. Devireddy is the site principal investigator of the SPYRAL trials at Emory.
SPYRAL HTN ON MED will include about 100 patients taking a stable regimen of three antihypertensive medications, and SPYRAL HTN OFF MED will include about 120 patients with hypertension who are not taking any antihypertensive medications.
Both studies will track the change in ambulatory systolic blood pressure as the primary outcome.
"Hypertension is a growing global epidemic," says Devireddy. "The SPYRAL trials will help us better determine if renal denervation is another way we can help our patients meet their blood pressure goals, especially those with resistant hypertension."
Other Emory investigators working on this study include Janice Lea, MD, and Bryan Wells, MD.
For more information on the SPYRAL trials at Emory, please call 404-686-7468. To learn more about the SPYRAL clinical trial program, please visit www.spyralhtntrials.com