UH Case Medical Center treats first patient in the world on international clinical trial for hypertension
CLEVELAND, Aug. 3, 2016 /PRNewswire/ -- University Hospitals Case Medical Center is the first site in the world to use a promising new technology for patients with high blood pressure. Led by Sahil Parikh, MD, the team performed the first procedure on a patient in RADIANCE-HTN, an international clinical trial evaluating the effect of the ReCor Paradise® Renal Denervation System on lowering blood pressure in patients with hypertension.
The new minimally invasive therapy was developed by ReCor Medical, Inc. to treat overactive nerves leading to the kidney, a process called renal denervation. RADIANCE-HTN uses high-intensity ultrasound energy (heat waves) aimed at decreasing the over-activity of these nerves, thereby lowering blood pressure.
"There is strong scientific rationale for this study to evaluate renal denervation as a treatment for hypertension," says Dr. Parikh, interventional cardiologist at UH Harrington Heart & Vascular Institute. "This may be a transformative trial if this treatment is found to help patients who have not been able to control their blood pressure and are therefore at extremely high risk for heart attack, stroke and kidney failure."
The new catheter-based technology uniquely delivers the ultrasound energy circumferentially to target the nerves. Disruption of the renal nerves has been shown in previous studies to prevent, delay or reduce the magnitude of hypertension.
RADIANCE-HTN is a blinded, randomized, sham-controlled trial designed to evaluate the blood pressure lowering effect of the Paradise System in two patient populations: patients currently uncontrolled on three or more blood pressure medications (termed "resistant hypertension") and in participants taking two or fewer blood pressure medications to manage their blood pressure. In the study, half the participants will receive the ultrasound therapy and half the patients will not receive ultrasound treatment; Patients will not know which treatment they receive.
The study is enrolling people between the ages of 18-75 with hypertension that may or may not be controlled with medication. UH is among 40 investigational sites in the US, UK, France, Germany and The Netherlands.
Hypertension is a major public health issue and one of the leading contributors to death from cardiovascular causes in the world. The World Health Organization (WHO) projects more than 1 billion people worldwide have high blood pressure. Despite lifestyle modification and use of multiple antihypertensive medications, roughly 50% of patients do not meet blood pressure goals. Uncontrolled hypertension is associated with severe consequences, including heart attack, stroke, and heart failure, among others.
"Many patients struggle to control their blood pressure on medication," says Dr. Parikh, who is also Assistant Professor of Medicine at Case Western Reserve University School of Medicine and director of the UH Harrington Heart and Vascular Institute Center for Research and Innovation. "We are pleased to participate in this important study evaluating if this new technology can become a treatment option for the millions of patients with hypertension."
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SOURCE University Hospitals Case Medical Center