HIGH BLOOD PRESSURE?
Learn about a clinical study of an investigational procedure.
THIS STUDY MIGHT BE RIGHT FOR YOU IF YOU ARE UNABLE TO CONTROL YOUR BLOOD PRESSURE.
Many patients with high blood pressure try to follow a healthy diet, exercise, and take medications — yet their blood pressure is still high.
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.
If you have been diagnosed with high blood pressure, you may qualify for a clinical study near you. Take our quiz to see if you qualify.
Closely monitor your blood pressure under the care of health care professionals.
THIS STUDY WILL
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.
in managing blood pressure. Sometimes, the nerves that control the kidneys become overactive, which can lead to hypertension.
DID YOU KNOW?
YOUR KIDNEYS PLAY AN IMPORTANT ROLE
or high blood pressure, is dangerous because it can lead to strokes, heart attacks, heart failure, or kidney disease. Reduction in blood pressure has been associated with reductions in stroke (reduced an average of 35%-40%), heart attack (20%-25%), and heart failure (more than 50%), according to research.¹
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.
Do you qualify for this study? Take our 2-minute quiz.
A nurse will evaluate your answers then reach out with more information on how to participate.
Caution: Investigational device. Limited by United States law to investigational use.
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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.