Nearly 6 million Americans have high blood pressure that resists treatment. They’ve tried pills, but their readings are still too high — making them prone to strokes and cardiovascular disease.
The Deborah Heart and Lung Center in Pemberton Township is one of 50 sites nationwide that has been selected for a clinical trial of a new procedure to help these hypertensive patients.
It’s called the Symplicity renal denervation system, developed by Medtronic, an international firm with U.S. headquarters in Minneapolis.
The procedure allows for a Symplicity catheter to be threaded through the femoral artery to the leading kidney arteries, where it ablates, or burns out, nerves that line the walls of the arteries.
“These nerves are part of the sympathetic nervous system, which is one of the pathways by which the body controls blood pressure. In people with resistant hypertension, the renal nerves could be hyperactive, raising blood pressure and contributing to heart, kidney and blood vessel damage,” Deborah researchers said in announcing the study.
By reducing the number of nerves, it reduces their ability to constrict blood vessels, raising blood pressure.
“The ablated nerves don’t send the signal to the brain to raise the pressure,” said Dr. Jon C. George, Deborah’s medical director of clinical research.
The Symplicity system has been used in Europe and is in clinical trials in the United States in hopes that it will be approved by the Federal Drug Administration, George said.
“In Europe, they have great results,” he said.
To qualify for the study, patients must be adults with a systolic blood pressure reading of 160 mmHG or higher, while using three or more antihypertensive medications. Deborah hopes to recruit about 10 people, who will be divided into those who receive the procedure and those who do not but think they did, so that researchers can see if the renal denervation works better than a placebo. One person already has participated in the study at Deborah.
The trial also is being conducted by the University of Pennsylvania Health System and Thomas Jefferson University Hospital, both in Philadelphia, and the Lankenau Medical Center in Wynnewood, Pa.
The procedure is performed during conscious sedation. Some of the study participants will undergo the actual procedure, while others will have the catheter inserted and feel as if it is being done.
“The study participants are blindfolded and get headphones,” George said. “It takes 20 minutes to do the procedure. They won’t be able to tell the difference whether they got the tube or not.”
The study will take two years to complete, as the patients’ blood pressure readings are followed after they had the actual ablation or placebo procedure.
Once the preliminary results are available, in about a year, those who do not get the actual procedure will be able to do so.
“Renal denervation and ongoing treatment with antihypertensive medications have the potential to help patients with this challenging form of hypertension achieve their target blood pressure levels,” said Dr. Richard Kovach, Deborah’s chairman of interventional cardiology and endovascular medicine and co-principal investigator of Symplicity.
Dr. David Hsi, Deborah’s chairman of cardiology and co-principal investigator, said the treatment “may represent a new and innovative approach to treating the growing number of treatment-resistant hypertension patients in the United States.”
For more information on the Deborah study, call 609-893-1200, ext. 5023.