Eligible candidates must be willing to undergo a minimally invasive procedure, all while being closely monitored by a team of medical professionals. In one study, candidates must be willing to stop taking blood pressure medications under the care of the study doctor for approximately 4 months.
This device is for investigational use and the goal of the study is to determine its safety and efficacy for hypertension. There are risks with any medical procedure and these will be explained to you by the study site.
Renal denervation is a minimally invasive procedure that uses an investigational device to treat overactive nerves in the kidney arteries. These nerves are known to affect blood pressure. The investigational device applies energy to these nerves in an attempt to reduce blood pressure long term.
This procedure can be performed in a single session by inserting a tiny tube into the arteries leading to the kidneys. Following study treatment, the device is removed.
Renal denervation is performed by a specially trained doctor. Study participants will be monitored by a team of healthcare professionals both before and after the procedure.
Closely monitor your blood pressure under the care of health care professionals.
Provide information about the safety and efficacy of renal denervation in patients whose blood pressure is not controlled.
Develop better technology to help others with high blood pressure in the future.
What is high blood pressure?
Blood pressure is defined by two numbers, systolic and diastolic:
Normal blood pressure is less than 120 mm Hg over 80 mm Hg (120/80). High blood pressure, or hypertension, is 140 mm Hg over 90 mm Hg and anything above that (140/90).
What is the investigational device and procedure used in this trial?
Renal denervation is an investigational therapy that applies energy to the nerves that line the kidney arteries in an attempt to reduce their effect on blood pressure. The procedure is performed by inserting a thin tube into the arteries leading to the kidneys. Following study treatment, the investigational device is removed. The procedure may potentially have effects on high blood pressure. There are risks with any medical procedure and these will be explained to you by the study coordinator.
Will all participants receive treatment?
Eligible participants will be randomly assigned to one of two groups: a treatment group that will receive study treatment, or a control group that will not receive study treatment. Participants will not be told which group they are assigned to for up to 6 months. Participants in the control group may be offered the procedure after 6 months.
How long is treatment?
After the procedure, participants can expect several 60-90 minute consultations for up to 3 months. Depending on the study, these may occur every 2 weeks or every 4 weeks. In one study, participants will have a visit at 4 months to adjust their medications if their blood pressure is not at goal. Participants will return at 6 months, and then annually at 12, 24 and 36 months.
Caution: Investigational device. Limited by United States law to investigational use.
All brand names are property of their respective owners. Use of these names does not imply endorsement.
1. Karnes JH, Cooper-DeHoff RM. Antihypertensive Medications: Benefits of BP Lowering and Hazards of Metabolic Effects. Expert review of cardiovascular therapy. 2009;7(6):689-702. doi:10.1586/erc.09.31.
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Last Update: 03/10/2018