Q: Can you write about the minimally invasive treatment that is being studied for uncontrollable hypertension?
A: The procedure is called renal denervation, and it is being studied in a large clinical trial in the United States as a treatment for resistant hypertension, defined as high blood pressure that is uncontrolled despite treatment with three or more hypertension drugs.
The study is being sponsored by Medtronic Inc., which makes a device to perform the procedure.
In renal denervation, a catheter or flexible tube is inserted through an artery in the groin and threaded to nerves near the kidneys that are involved in blood pressure regulation.
The catheter delivers bursts of radiofrequency energy to the nerves, deactivating them. The catheter is then removed. Patients are under conscious sedation during the procedure.
In previous studies, some patients saw a drop in blood pressure over the next three to six months, and in some, that reduction was still present two years out.
Medtronic announced in October that the new study had enrolled its first patient. An estimated 530 people will be enrolled at 60 medical centers. A map on the study's website does not show any Virginia study sites. The closest is Duke University in North Carolina.
In the clinical trial, patients are being randomly assigned to one of two groups — a group getting the denervation treatment or a group getting standard medical treatment with drugs.
Study participants will be followed for six months.
The study is a phase three clinical trial, a pivotal study that will give federal medical device regulators information they need to determine whether the device works well enough and is safe enough to become widely available.
More information on the study can be found at ClinicalTrials.gov.
Renal denervation clinical trials are also under way in Europe.
In the U.S. study, eligible participants have to be 18 to 80 years old and on blood pressure medication but not getting good results — their top blood pressure number has to be 160 or more.
The study excludes people with impaired kidney function, with Type 1 diabetes, who require oxygen support, who have primary pulmonary hypertension or who are pregnant.
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