Houston Methodist DeBakey Heart & Vascular Center has been selected to participate in a clinical trial to evaluate the safety and effectiveness of a medical device intended to help treat high blood pressure in patients whose blood pressure is not controlled, despite treatment with multiple blood pressure medications.
Why is this study being done?
Research suggests that 28 percent of treated hypertensive individuals are considered resistant to treatment, and these patients have a threefold increase in the risk of cardiovascular events compared with individuals with controlled high blood pressure.1
This study is being conducted to test a procedure called renal denervation. Renal denervation is a minimally invasive, catheter-based procedure that regulates the output of 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 hypertension, the renal nerves are hyperactive, raising blood pressure and contributing to heart, kidney and blood vessel damage.
Renal deneveration can now be tested in clinical trials with an experimental medical device called the Symplicity® Catheter System™. The maker of the device, Medtronic, is sponsoring this study to continue to evaluate the device and the renal denervation procedure.
Who is eligible?
Patients eligible for this trial are people with extreme high blood pressure whose hypertension is not being adequately controlled with medication. If you are taking three or more blood pressure medications, have a systolic blood pressure higher than 160 mmHg, and are between the ages of 18 and 80, you may be eligible for this study.
What will the study entail?
The procedure involves placing a catheter (tube) and a radiofrequency-generator (RF-generator) into your blood vessels and applying brief low-level radiofrequency (RF) energy through the wall of the blood vessel to the kidney (renal artery) to disrupt the nerves that lead to the kidney (renal denervation).
How can I find out more?
To learn more about the Medtronic study at the Houston Methodist DeBakey Heart & Vascular Center, please contact Paula Juarez, Study Coordinator, at 713-441-3672, or send an email to firstname.lastname@example.org.
1Doumas M et al. Benefits from treatment and control of patients with resistant hypertension. International Journal of Hypertension 2011. Article ID 318549, 8 pages, 2011.