Patients with hypertension whose blood pressure cannot be brought down to safe levels despite taking three or more medications may have some relief coming their way. An innovative, first-of-its-kind clinical trial for a device representing a dramatic shift in treatment approaches for the toughest-to-treat patients is currently being conducted at NewYork-Presbyterian Hospital.
Clinical trials of the Symplicity renal denervation system from Medtronic are underway at both NewYork-Presbyterian Hospital/Weill Cornell Medical Center and NewYork-Presbyterian Hospital/Columbia University Medical Center, which is the leading clinical-trial site in metropolitan New York. If successful, this investigational procedure -- which deviates from traditional pharmaceutical therapies in favor of a minimally invasive procedure that aims to down-regulate overactive nerves in the body that can cause rising blood pressure -- could turn the tide for the many Americans affected by treatment-resistant hypertension.
"Hypertension is a serious health problem, and those with drug-resistant hypertension are at the greatest risk of developing organ damage, including heart attack, stroke and death," says Dr. Ajay J. Kirtane, an interventional cardiologist and chief academic officer of the Center for Interventional Vascular Therapy at NewYork-Presbyterian/Columbia University Medical Center. Dr. Kirtane is leading the study at NewYork-Presbyterian/Columbia. "In earlier studies, the Symplicity renal denervation system reduced systolic blood pressure by an average of 33 millimeters, a remarkable amount for patients with such severe hypertension. If the results are duplicated in this pivotal clinical trial, we may have discovered an effective treatment that will help millions of Americans."
"The Symplicity renal denervation system may someday be an attractive alternative for patients in the U.S. who have uncontrolled hypertension despite treatment with many medications," says Dr. Samuel J. Mann, a leading hypertension specialist at NewYork-Presbyterian/Weill Cornell and professor of clinical medicine at Weill Cornell Medical College, who is leading the study at NewYork-Presbyterian/Weill Cornell.
Researchers think that hyperactivity of the sympathetic nervous system, which connects the brain, heart, blood vessels and kidneys -- each of which plays an important role in blood pressure -- contributes to resistant hypertension. The Simplicity renal denervation system seeks to reduce the drive of the sympathetic nervous system by preventing it from sending out erroneous signals to the brain to increase blood pressure.
