Stamford Health Launches Clinical Trial On Hypertension

From Stamford Health: Doctors and researchers at Stamford Health are leading Connecticut’s only site for the ongoing RADIANCE-HTN study. The multicenter, international trial is conducted at centers in the United States and in Europe with the aim of investigating whether endovascular ultrasound-based renal denervation reduces blood pressure in patients with mild to moderate hypertension (RADIANCE-HTN SOLO Cohort) or treatment resistant hypertension (RADIANCE-HTN TRIO Cohort). Hypertension (high blood pressure) affects 1 in 3 American adults. Common symptoms of hypertension include chest pain, impaired vision, fatigue, and irregular heartbeat. If untreated, hypertension can lead to health conditions such as heart disease and stroke.

The study is open to patients between the ages of 18-75 who have a documented history of hypertension. The trial is a randomized, double-blind, sham-controlled study designed to evaluate the safety of the Paradise Renal Denervation System to reduce blood pressure. Patients either receive ultrasound renal denervation (treatment) or renal angiogram only (sham control). If the patient is eligible for the trial, they are selected at random for treatment or sham in one of the two cohort groups. Enrollment in the SOLO cohort has been completed whereas enrollment in the TRIO cohort is on-going.

The initial data from the SOLO cohort demonstrates that patients who received renal denervation exhibited a significant reduction in blood pressure with little to no safety concerns. Furthermore, patients were less likely to require medications to control their blood pressure. All SOLO patients will continue to be evaluated for 3 years.

“We are excited to be a part of this important study that is not only advancing our knowledge about treatment for hypertension, but also allows certain patients the ability to potentially take fewer or no hypertension medications,” said Dr. David Hsi, Chief of Cardiology and Co-Director of the Stamford Health Heart and Vascular Institute (HVI), who is serving as principal investigator of the RADIANCE-HTN trial. “In fact, up to a quarter of patients with hypertension have difficulty tolerating hypertension medications or are unable to be controlled by these medications. This is also especially great news for younger patients who may not need to rely on hypertension medication for the rest of their lives.”

“We’ve been actively recruiting patients for the trial, and we’re receiving a response from patients because they have strong interest in controlling their blood pressure,” said Suzanne Rose, MS, PhD, CCRC, Director of Office Research, Stamford Health. “Initial data shows that patients have been able to stay off their blood pressure medication or they’re able to reduce their blood pressure medication. There has been a significant decrease in their blood pressure after this procedure.”

The minimally invasive procedure behind the RADIANCE-HTN trial involves the delivery of ultrasound energy to control blood pressure and treat hyperactive renal nerves. A small catheter is inserted into the renal artery, and ultrasound energy (heat) is delivered through the tissue surrounding the artery, to interrupt the signaling of the renal nerves. By treating these nerves which run to the kidney, blood pressure may decrease. After both kidneys are treated, the catheter is removed, leaving nothing behind.

After the procedures by Dr. Scott Martin, Director of Interventional Cardiology or Dr. Edward Portnay, Director of Cardiac Catheterization Lab, Dr.. Hsi and other Stamford Health physicians monitor each patient’s results and experiences through various follow-up visits over the course of the next three years.

Six months after the procedure, participants will learn if they received the therapy. Those who did not receive therapy may have the opportunity to undergo the procedure.

For more information, please visit the hospital’s Heart & Vascular Institute.

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