This trial located in United States aims to examine whether using radiation to destroy nerves of the kidney can help control hypertension (high blood pressure). The outcome to be studied is the safety and blood pressure changes.
The details
The kidneys play an important role in regulating blood pressure. Previous research has shown that cutting off the nerve supply to the kidneys might decrease blood pressure. In the past, a surgical procedure was used to cut the nerves, but this surgery is no longer commonly performed. The Beta-Cath 3.5F system (Novoste) uses a small amount of radiation to cut off nerve supply. Novoste has previously been used for treating blood vessels of the heart. Hence, it is suggested that Novoste can help decrease blood pressure in patients with uncontrolled hypertension by decreasing the nerve stimulation to the kidneys.
Who are they looking for?
This study is recruiting patients aged 18-85. Patients should be receiving a stable drug regimen including 3 or more anti-hypertensive medications for at least 1 month (including one diuretic - drug that causes increased urination) that is expected to be maintained for at least 6 months. Patient's kidney arteries should be less than 2.75 mm in diameter.
Patients should not have had more than 1 hospital admission for hypertensive crisis (severe hypertension event) within the past year. Patients should not have orthostatic hypotension (low blood pressure when standing up). Patients should not have primary pulmonary hypertension (high blood pressure of lung arteries). Patients should not have significant disease of the heart valves.
How will it work
All patients will be randomly assigned to 1 of 2 treatment groups. Patients in the first group will receive a radiation dose of 25 Gy (a measure of radiation) to the blood vessels of the kidney. Patients in the second group will receive a radiation dose of 50 Gy. All patients will continue to receive anti-hypertensive medication and they will be followed-up for 2 years.
