Can high blood pressure be safely reduced and controlled by “disconnecting” nerves in the kidneys? That is a question that a new clinical study called Symplicity HTN-3 at University Hospitals Case Medical Center (UHCMC) hopes to answer.
The study will enroll people who have resistant hypertension, meaning that their blood pressure remains extremely high despite taking three or more medications. UH is a clinical site for the five-year national study funded by Medtronic and is one of 90 sites in the nation that will enroll more than 500 people with high blood pressure resistant to medical therapy into the study. It will involve a novel multi-disciplinary approach to hypertension treatment using cardiac and kidney specialists.
In the Symplicity HTN-3 clinical study, research subjects will be randomly assigned to one of two groups: One-third will continue the best available medical treatment and two-thirds will combine the best available medical treatment with a procedure where participants will have the nerves in their renal arteries disrupted with radio frequency energy that generates heat. The process is called renal denervation.
An earlier study (Symplicity HTN-2), performed in Europe and Australia, found that patients who underwent renal denervation experienced a nearly 30mmHg of systolic blood pressure reduction compared to treatment with medications alone. Symplicity HTN-3 will be a much larger trial conducted entirely in the U.S.
The denervation of the kidney arteries will be performed in the cardiac catheterization lab. The procedure itself takes about 45 minutes and involves using low level radio frequency energy to heat the tissue in the renal artery just enough to eliminate the nerves without hurting the arterial wall. Patients generally experience minimal discomfort during the procedure. So far, long-term side effects have been minimal in the patients treated in Europe and Australia.
The study is currently enrolling patients 18 to 80 years old. For more information about enrollment criteria, visit ClinicalTrials.gov, study identifier: NCT01418261.