This trial will evaluate the effectiveness and safety of a device to manage hypertension. The main outcomes will be the rate of adverse events (AEs) and blood pressure (BP) changes. This trial is taking place in the United States.
Hypertension or high blood pressure (BP) is a common and serious condition. Patients with uncontrolled hypertension are at risk of other conditions. This includes heart disease, stroke, and diabetes. Hypertension can be treated using a number of strategies. This includes medication to reduce BP. Some patients do not respond well to medication. In some cases, patients may take several drugs and their BP is still high. Renal denervation (RDN) is a minimally invasive surgical procedure. It uses ultrasound waves to reduce the activity of the renal nerve which is located on the kidneys. This can improve BP control.
This trial will evaluate the effectiveness and safety of a device to manage hypertension. The main outcomes will be the rate of AEs and BP changes.
Who are they looking for?
This study will recruit 225 participants with stage 2 hypertension. BP levels of greater than 140/90 mmHg and less than 180/120mmHg are accepted. Patients must be prescribed medication to treat hypertension.
Patients cannot take part in the trial if their renal artery is not suitable for the procedure. Patients with poor kidney function and diabetes are excluded from the trial. Other exclusion criteria include a known secondary cause of hypertension, history of serious heart or brain events (e.g. heart attack, stroke) and pulmonary hypertension.
How will it work
Patients will undergo a renal angiogram (imaging test to look at the blood vessels in the kidneys). This will involve a small incision in the groin. A catheter will be inserted into the renal vein. The device will be delivered to the tissue beside the renal artery. The device will emit ultrasound waves. The device will be removed and the incision will be closed.
The main outcomes will be the rate of AEs and BP changes after 2 months.