Spyral and Rox Trials at Piedmont

Dear Colleagues,

This month, at the European Society of Cardiology Scientific Sessions, we will present the results of the Spyral renal denervation program, and the results will be simultaneously published in a major medical journal. Although the results are currently embargoed, plans are forthcoming for a US pivotal trial. Our patients will soon learn of the results in the media, and we want them to know these opportunities are available within the Piedmont Healthcare system.

Piedmont Heart has been a leading center worldwide in novel therapies for patients with uncontrolled hypertension. As a leading enrolling center in such studies, I am writing to enlist your contribution to two ongoing trials at Piedmont Heart:

SPYRAL

Spyral is an ongoing continuation of the renal denervation trial presented this month. It includes patients either on or off antihypertensive therapy with a systolic blood pressure between 150 and 180 mm Hg and diastolic pressure above 90 mm Hg. Patients in the on medications arm of the study may be taking any or all of the following medications: an ACE inhibitor, diuretic, calcium channel blocker and/or beta blocker. Patients in the off medications cohort may be either drug naïve/intolerant or transiently stopped from their medications for a brief period. (This latter method is how pharmaceutical trials are currently performed under FDA guidance.)

 ROX

The Rox trial employs an arteriovenous coupler device that causes an immediate, significant, and sustained decrease in blood pressure. This self-expanding, stent-like device exploits the mechanical effects of the creation of a low-resistance, high-compliance venous segment to the central arterial tree and can be implanted in a standard catheterization laboratory under fluoroscopic guidance. Similarly, the trial is enrolling patients with a systolic blood pressure >155 mm Hg (1) on diuretic therapy and at least 2 other anti-hypertensive drugs, or (2) intolerance to at least 3 classes of anti-hypertensive therapy.

Both trials are randomized to therapy versus control, and they are presently enrolling at Piedmont. We welcome your referral of potentially eligible patients with moderate, uncontrolled hypertension. We will readily evaluate patients for eligibility and contact them with your permission. Please note that these patients will continue to receive care in your clinics in parallel with their participation.

 For potentially eligible patients, please contact us:

Shan Liu, RN               shan.liu@nullpiedmont.org; tel: 404 323 5936

David Kandzari, MD    david.kandzari@nullpiedmont.org; tel: 404 985 3746

Thank you for making Piedmont a leading center to offer novel therapies for patients previously considered to have limited or no treatment alternatives.

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