CLEVELAND -- University Hospitals Case Medical Center clinical trial investigates if denervating kidney nerves reduces blood pressure.
Part of a national study that will enroll 500 patients and asks, 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 (UH) Case Medical Center 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. It 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. UH will enroll one to two patients per month during the initial phase of the study.
At UH, the trial is coordinated by the UH Harrington Heart & Vascular Institute and the Clinical Hypertension Program. It will involve a multi-disciplinary approach to hypertension treatment involving 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. (Systolic blood pressure refers to the peak pressure in the arteries and is the top number in a blood pressure reading, which is measured in millimeters of mercury, written as mmHg.)
Symplicity HTN-3 will be a much larger trial conducted entirely in the US. The denervation of the kidney arteries will be performed in the cardiac catheterization lab by Dr. Parikh and colleagues, including Dr. Marco Costa, Director, Interventional Cardiovascular Center, UH Harrington Heart & Vascular Institute, and Dr. Vikram Kashyap, Co-Director, UH Harrington Heart & Vascular Institute and Chief, Division of Vascular Surgery and Endovascular Therapy.
The procedure takes around 45 minutes causes minimal discomfort. So far, long-term side effects have been minimal in the patients treated in Europe and Australia.
Hypertension is one of the leading contributors to death from cardiovascular causes in the world. Nearly 1 billion patients worldwide have hypertension requiring therapy. The study is currently enrolling patients 18 to 80 years old.
For more information about enrollment criteria, visit ClinicalTrials.gov, study identifier: NCT01418261, or contact at UH: Terence Semenec, RN at 216-983-4724 or Terence.Semenec@uhhospitals.org