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Pivotal Clinical Trial Investigates New Technology for Managing Uncontrolled Hypertension


Uncontrolled hypertension is a leading risk factor for cardiovascular disease related morbidity and deaths. Hypertension is now so widely prevalent that the World Health Organization has declared it a global public health crisis that affects one billion people worldwide. An estimated 360,000 deaths per year in the United States have hypertension as the primary or a contributing cause.

Despite the existence of effective antihypertensive drugs and diligent primary care oversight, arterial hypertension remains a critical challenge for many patients, even when combined with significant lifestyle changes. In fact, 50 percent of patients with high blood pressure do not meet treatment goals, and nonadherence is high which creates a pressing unmet need for new forms of treatment.

TriStar Centennial Heart and Vascular is currently enrolling patients in a pivotal clinical trial to determine the safety and effectiveness of an investigational renal denervation device (RDN) used to help lower blood pressure in patients with uncontrolled hypertension. TriStar Centennial Heart and Vascular is the only site in the region where the Spyral HTN trial is available. It is an innovative tool that may prove effective for treatment of uncontrolled hypertension.

Uncontrolled hypertension is blood pressure ≥140/90 mm Hg despite treatment with optimal doses of three different anti-hypertensive drugs, one of which should be a diuretic. Uncontrolled hypertension also is defined in instances where an individual's blood pressure is at target levels but four or more antihypertensive drugs are required. Those with uncontrolled hypertension have double the risk of cardiovascular events than those without uncontrolled hypertension.

Research has shown that the kidneys play an important role in managing high blood pressure. Sometimes, however, the nerves that control the kidneys become over-active and lead to high blood pressure.

Renal denervation is an investigational therapy that consists of a minimally invasive procedure. Using active energy, overactive nerves that lead to the kidneys are adjusted from within each renal artery, potentially helping to balance overactive signaling. The patient is mildly sedated while the cardiologist performs the procedure in a single session by inserting a catheter into the femoral artery to access the nerves in the walls of the renal arteries. Controlled radio-frequency energy is administered in short bursts to ablate the targeted nerves.

The Spyral HTN trial is randomized, controlled and blinded to study the effectiveness of the technology versus placebo.

An 80-patient pilot study of the device published last year demonstrated clinically relevant reductions in both office and 24-hour systolic blood pressure. Notably, those blood pressure lowering effects were observed not only throughout the daytime, but also during the nighttime and early morning periods when heart attack and stroke risk due to hypertension are highest.

Blood pressure during sleep is the most significant predictive marker of cardiovascular disease morbidity and mortality, and reduction in asleep blood pressure is associated with highly significant reduction of cardiovascular disease risk. While the efficacy of anti-hypertension medications can fluctuate throughout the day, this pilot study resulted in the important observation that renal denervation is "always on."

To be eligible, patients must be between the ages of 20 and 80 and have uncontrolled hypertension with systolic readings between 150-180 mm Hg and diastolic readings above 90 mm Hg. Participants will be required to attend regular check-ups, wear an ambulatory blood pressure monitor, and agree to discontinue their blood pressure medications through their 3 month follow up period. After the 3 month follow up period, subjects may resume pharmacological blood pressure therapy in consultation with their doctor in order to obtain optimal blood pressure control.

The screening process for enrolling in the trial is about a month long and involves monitoring blood pressure and medication compliance. The investigational procedure itself lasts about an hour and requires an over-night hospital stay. Post-procedure follow-up will take place in the Hypertension Clinic at TriStarCentennial Heart and Vascular.

The multidisciplinary team at TriStar Centennial Heart and Vascular is proud to help create innovations in patient care that improve their quality of life and lower their risks for more serious cardiovascular complications.

For more information about the Spyral HTN trial and to refer a patient for enrollment consideration, call 615-329-7641.

Brian Jefferson, MD, is an Interventional Cardiologist at Centennial Heart TriStar Centennial Medical Center


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