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First Subject Receives Experimental Hypertension Treatment
University Hospitals Case Medical Center in Cleveland, Ohio, is the first site in the world to use a new technology for patients with hypertension. Led by Sahil Parikh, MD, the team performed the first procedure on a subject in the international RADIANCE-HTN trial, which is evaluating the effect of the ReCor Paradise renal denervation system in lowering blood pressure in patients with hypertension.
The minimally invasive therapy was developed by ReCor Medical, Inc., to treat overactive nerves leading to the kidney. The RADIANCE-HTN trial is using high-intensity ultrasound energy (heat waves) aimed at reducing the overactivity of these nerves, thereby lowering blood pressure.
“There is strong scientific rationale for this study to evaluate renal denervation as a treatment for hypertension,” Parikh said. “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 catheter-based technology 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.
The RADIANCE-HTN trial is a blinded, randomized, sham-controlled study designed to evaluate the blood pressure-lowering effect of the Paradise system in two cohorts: subjects currently uncontrolled on three or more blood pressure medications (termed “resistant hypertension”) and subjects taking two or fewer blood pressure medications to manage their hypertension. Half of the subjects will receive the ultrasound therapy, and half will not.
The study is enrolling adult subjects 18 to 75 years of age with hypertension that may or may not be controlled with medications. University Hospitals Case Medical Center is among 40 investigational sites in the U.S., United Kingdom, 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 estimates that more than 1 billion people worldwide have the disorder. Despite lifestyle modification and the use of multiple antihypertensive medications, approximately 50% of patients do not meet their blood pressure goals. Uncontrolled hypertension is associated with severe consequences, including heart attack, stroke, and heart failure.
Source: UH Case Medical Center; August 1, 2016.