What is high blood pressure?
Blood pressure is defined by two numbers, systolic and diastolic:
- Systolic= blood pressure in the arteries as your heart beats (upper number)
- Diastolic= blood pressure in the arteries between the beats (lower number)
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.