Archives     Advertise     Editorial Calendar     Subscribe     Contact Us    

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


Related Articles:

Recent Articles

Self-Care on the Front Lines of Coronavirus

Physicians, nurses, respiratory therapists and the full complement of support staff at hospitals and clinics are battling coronavirus on the front lines. When caring for others, it's all too easy to forget to take care of yourself.

Read More

The Onsite Foundation Announces New Virtual Support Group for Frontline Healthcare Workers and Medical Staff as part of 'Support in Service' Program

The Onsite Foundation, a 501(c)(3) non-profit public charity, today announced a new support group offering under the Foundation's 'Support in Service' program for frontline healthcare workers and medical staff across the country affected by the COVID-19 pandemic.

Read More

New Study Looks at Cost Impact of OTC Birth Control

A new study explores the impact on unintended pregnancies, consistent use of progestin-only OTC birth control pills at various price points.

Read More

Behavioral Health in a Time of Social Isolation

Last month, the Nashville Health Care Council brought together experts for a virtual panel discussion on behavioral health in the midst of social distancing orders.

Read More

COVID-19 & Mental Health

As the virus takes its toll, providers are finding new ways to reach patients and preparing for the mental health fallout ahead.

Read More

Sharing Best Practices in Behavioral Health

Nashville-based online video service provides evidence-based training to public and providers.

Read More

May is Mental Health Month

May is Mental Health Month with excellent resources from national organizations for both patients and providers.

Read More

Business Insights

Read More

Celebrating 15 Years of Incredible Leaders

Following are the 15 classes of Women to Watch. Some of these trailblazers have happily retired after a career of service. Others have moved to other positions and taken up new challenges since they were first recognized.

Read More

New Study Looks at Cost Impact of OTC Birth Control

A new study explores the impact on unintended pregnancies, consistent use of progestin-only OTC birth control pills at various price points.

Read More

Email Print



Powered by Bondware
News Publishing Software

The browser you are using is outdated!

You may not be getting all you can out of your browsing experience
and may be open to security risks!

Consider upgrading to the latest version of your browser or choose on below: