Symplicity Trial Brings Hope for Patients with Severe Hypertension

Symplicity toolFor years, Dr. George Vetrovec has been frustrated by the lack of options for patients with severe high blood pressure that does not respond to medication. Now, he’s hoping his work on a clinical trial will give these patients a new course for treatment.

The Symplicity HTN-3 study involves an investigation of the safety and effectiveness of using the Symplicity Catheter to help patients with “really severe hypertension that’s not well-managed. It’s intractable, despite maximal medical treatment,” says Dr. Vetrovec, Director of the VCU Pauley Heart Center’s Adult Cardiac Catheterization Laboratory.

Dr. George Vetrovec and Dr. Dominic Sica

Dr. Vetrovec and Dr. Dominic Sica, a VCU nephrologist, are the co-principal investigators for the VCU component of the trial, which began its third phase in September 2011. The Pauley Heart Center is one of 90 centers nationwide participating in the study.

Using the special catheter, Dr. Vetrovec delivers radiofrequency energy through the luminal surface of the renal artery. He explained how this procedure, known as renal denervation, works: “You have nerves that run from the kidneys to the brain that contribute to high blood pressure. When you burn this part of the renal artery, you are burning the nerves that normally would stimulate the kidney, often leading to hypertension.” The procedure is completed 
in one short session.

Patients who qualify for the study have uncontrolled high blood pressure despite 
being on a regimen of three or more anti-hypertensive medications, including a diuretic. If the Symplicity Catheter proves to be effective in trials, it may one day be approved by the FDA as a new therapy.

Kidney and renal arterySo far, says Dr. Vetrovec, “Data from previous trials suggests blood pressure drops with the ablations and continues to drop even two to three years later.” He is excited about the possibility of a new therapy for these patients. “There really isn’t anything else out there,” he says.