RADIANCE-HTN & RADIANCE-II Clinical Studies

If you have hypertension, you are not alone. Learn about the following clinical studies for the potential treatment of high blood pressure.

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Hypertension (High Blood Pressure)

Worldwide there are over 1 billion people with hypertension, and this number is expected to grow to 1.5 billion in a few years. Hypertension is important for many reasons, but the most important reason is that hypertension has been shown to increase the risk of heart disease, kidney disease, vascular disease, and stroke.

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Hypertension

What is Hypertension?

Blood pressure is the force of blood against your artery walls as it circulates through your body. Blood pressure naturally rises and falls throughout the day, but it can cause problems if it stays too high for a long time. The medical term for high blood pressure is “hypertension” — it is sometimes referred to as “the silent killer” because frequently people don’t even know they have it. High blood pressure can have no symptoms or warning signs. High blood pressure generally develops over years. Hypertension is more common as people age. Your diet, including excessive alcohol intake and smoking, as well as being overweight, can contribute to the development of hypertension.

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Blood Pressure

What Causes Hypertension?

Blood pressure is controlled by a complex interaction of signaling from several systems within the body including the nervous system, circulatory system, and endocrine (hormonal) system. Increased activity of the sympathetic nervous system (“fight or flight” system) can affect the blood vessels and the hormonal system resulting in elevated blood pressure (hypertension). The nerves running to the kidney are especially important in the control of blood pressure.

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Is There a Treatment?

Sometimes people can keep blood pressure in a healthy range simply by making lifestyle changes, such as losing weight, increasing activity and eating more healthfully. Others will need to add medications to their lifestyle modifications. A wide variety of medications are available for treating high blood pressure — and several are often used together to achieve results. For some people, even with lifestyle changes and medications, it may be difficult to control high blood pressure. Recently, however, new technologies have been developed that seek to decrease the over-activity of the sympathetic nervous system to lower blood pressure.

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The Paradise® Renal Denervation System

The Paradise Renal Denervation System is a minimally invasive procedure to treat overactive nerves leading to the kidney. The treatment involves a small incision made in the upper thigh. A small flexible catheter is then inserted and placed in the artery supplying the kidney. Ultrasound energy (sound waves) is delivered to the tissue surrounding the artery for several seconds. The ultrasound energy generates heat to decrease the over-activity of the nerves leading to the kidney. Both kidneys are treated. Following treatment, the device is removed.

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The Radiance HTN Clinical Study

The RADIANCE-HTN clinical study is a randomized, controlled study to provide additional information about the Paradise Renal Denervation System intended to treat high blood pressure. The study is designed to evaluate the Paradise Renal Denervation System in patients currently uncontrolled on three or more blood pressure medications. These patients are referred to as the “TRIO cohort.” In the study, half the participants will receive the ultrasound therapy and half the patients will receive a “sham” therapy (control group that does not receive ultrasound treatment).

Participants will not be told which group they are in. Participants in the control group may have the opportunity to have the therapy at a later time.

Under the leadership of Kintur A. Sanghvi, MD, Cardiac Interventionalist and Associate Medical Director, Deborah Heart & Lung Center has become one of the leading enrolling global research center in the RADIANCE-HTN TRIO cohort.

Catheter The Paradise Renal Denervation Catheter within the artery. The red circle represents the heat generated from the ultrasound energy within the artery. The blue circle represents active cooling from circulating water within the Paradise Catheter, to protect the artery from heat.

Rings The opaque rings illustrate the heart deposited in the tissue, to decrease the over-activity of the nerves leading to the kidney. Each ring represents one 7-second treatment. Two to four treatments will be delivered to the left and right arteries supplying the kidney.

Clinical studies with the Paradise Renal Denervation System have indicated that the therapy may be effective in reducing blood pressure in patients with Resistant Hypertension.

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Am I a Candidate for the RADIANCE-II Study?

Are you between 18 and 75 years of age, and . . .

  • Your blood pressure is greater than 140/90 mmHg despite being prescribed blood pressure medications?
  • Your blood pressure is controlled (less than 140/90 mmHg) by one or two blood pressure medications but you would be interested in trying an alternative to medications?
  • Have you been diagnosed with high blood pressure but do not want to start taking medication?

See if You Qualify

The RADIANCE-HTN and RADIANCE-II studies are enrolling people ages 18 to 75 years who are struggling to manage their blood pressure.

To see if you might qualify for either RADIANCE clinical study, and to get connected directly with a research nurse, please take the questionnaire at www.HighBPtrial.com.

If you prefer to take the questionnaire over the phone, please call, toll-free 866-461-7472.

Additional resource information can be found at ClinicalTrials.gov, a resource provided by the U.S. National Library of Medicine.

More information and study details for Radiance HTN

More information and study details for Radiance II

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