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  • Renal Denervation in Patients with Uncontrolled Hypertension (Symplicity HTN-3)

  • Renal Denervation (RDN) Treatment

    One of the body's primary methods for controlling blood pressure involves the sympathetic nervous system. This system includes the major organs that are responsible for regulating blood pressure: the brain, the heart, the kidney and the blood vessels themselves. One key player in long term blood pressure regulation is the kidney. Renal nerves communicate information from the kidney to the brain, and vice versa. In people with hypertension, the renal nerves are hyperactive, which raises blood pressure and contributes to heart, kidney and blood vessel damage.

    Renal Denervation (RDN) treatment is being studied in a clinical trial to learn whether renal denervation is a safe and effective treatment option to lower blood pressure for certain patients with uncontrolled hypertension. The Symplicity HTN-3 clinical trial will attempt to disrupt the hyperactive nerves by applying brief radio frequency (RF) energy near the nerves with an experimental medical device.

    The Symplicity HTN-3 study is a, multi-center, prospective, single-blind, randomized, controlled study of the safety and effectiveness of renal denervation in subjects with uncontrolled hypertension. Bilateral renal denervation will be performed using the Symplicity Catheter - a percutaneous system that delivers radiofrequency (RF)energy through the luminal surface of the renal artery.

    Eligiblity

    Patients must be between 18 and 80 years old, have an office systolic blood pressure greater than or equal to 160mmHg, and are on at least 3 different anti-hypertensive medications.

    You may be eligible to participate if you:

    • Are between 18 and 80 years of age
    • Have high blood pressure
    • Are taking 3 or more medications for your blood pressure

    Participation includes:

    • Several clinic visits over a 3-year period, including blood draws and urine samples
    • 24-hour ambulatory blood pressure monitoring
    • Home blood pressure monitoring
    • A study procedure that includes an angiogram (x-rays of the blood vessels to your kidneys)
    • Ultrasound of your kidneys
    • Overnight hospital stay with the study procedure

    More Information

    Sponsored by Medtronic: http://www.symplifybptrial.com/.