The RADIANCE-HTN Study: A Study of the ReCor Medical PARADISE System in Clinical Hypertension Save

Date Added
January 12th, 2016
PRO Number
Pro00051260
Researcher
Thomas Todoran
Keywords
Cardiovascular, Hypertension/ High Blood Pressure
Summary

This is a clinical study looking at the effectiveness and safety of a new device call The Paradise System to use for renal denervation in patients who have mild to resistant hypertension. The study is divided into two groups, those on one to two anti hypertensive medications and those on three or more. For those only taking one or two medications, they will stop their current blood pressure medication while monitoring their blood pressure. Those who are taking 3 or more blood pressure medications will stop their current medication regime and be given one of two combination medications while monitoring their blood pressure. In each of the groups have the patients, if and when they continue to meet study inclusion criteria, will be randomized to undergo a renal denervation procedure using the new system vs no procedure. Their assignment will not be made known to them. All groups will be follow up to 3 years but for patients who did not initially have the procedure will be allowed to do so after one year. The goal of the renal denervation is to lower blood pressure by using ultrasound waves to heat and disable the nerves surrounding the blood vessels leading to the kidneys. It is believed these nerves may be too active in patients with high blood pressure.

Institution
MUSC
Recruitment Contact
Vijay Paladugu
843-876-5783
paladugc@musc.edu

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