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Clinical Trial for Treatment Resistant Hypertension

In the United States, approximately 65 million people suffer from hypertension (high blood pressure), and 20 percent to 30 percent of them have uncontrolled hypertension despite taking medication. Hypertension is called resistant if a person’s blood pressure remains above goal despite their taking three medications to treat it. As part of a national clinical trial, Jobst Vascular Institute is evaluating a device that has shown promise in treating people with resistant hypertension.

Many factors can contribute to resistant hypertension, including lifestyle factors such as obesity, alcohol use, common over-the-counter analgesics, oral contraceptives, and herbal compounds as well as renal disease, sleep apnea, and not properly taking medication.

Your body’s natural mechanism for controlling blood pressure is known as spontaneous baroreflex sensitivity. Some patients who have treatment resistant hypertension have impaired spontaneous baroreflex sensitivity. Currently, there are existing clinical trials that are testing tiny devices that stimulate your body’s natural blood pressure control.

A new fully implantable device designed to electrically stimulate the carotid baroreflex to decrease blood pressure is currently in Phase II trials. The Rheos® Hypertension Therapy System (CVRx®, Minneapolis, MN) consists of three components: an implantable pulse generator, carotid sinus leads, and an external programmer system allowing the physician to set patient-specific dosing. This system uses CVRx-patented Baroreflex Activation TherapyTM (BATTM) technology that is designed to trigger the body's own natural BP regulation system to control blood pressure. Reports from a multicenter feasibility study suggest that treatment with the Rheos device significantly reduces BP in participants with few adverse outcomes.

Though the Rheos Pivotal Trial to evaluate the safety and effectiveness of the device is now closed for enrollment, you can keep an eye out for exciting developments in clinical research by downloading a list of JVI’s currently enrolling clinical trials.

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