Simplicity HTN-3 Clinical Trial to Determine Safety and Efficacy of Renal Denervation System
Pontiac, Mich.—St. Joseph Mercy Oakland (SJMO) has embarked on an investigational study of a medical device leading to a revolutionary treatment for hypertension (high blood pressure) in people whose blood pressure is not controlled, despite treatment with multiple medications. SJMO is one of five sites in Southeast Michigan and 90 across the U.S. participating in the study.
Sponsored by Medtronic, the Symplicity HTN-3 study will focus on the safety and efficacy of the company’s Symplicity © Renal Denervation (RDN) System™ using an experimental medical device called the Symplicity ® Catheter System ™.
In earlier Symplicity HTN-1 and HTN-2 studies in Europe and Australia, this approach was found to substantially reduce blood pressure. The Symplicity HTN-3 trial is designed to build upon that evidence and support the application for approval in the U.S.
“These early clinical studies have demonstrated significant decreases in blood pressure among those with hypertension,” said Kirit Patel, MD, principal investigator and chair of the SJMO Division of Cardiology. “RDN has the potential to revolutionize the treatment of hypertension.”
In addition to Dr. Patel, the SJMO clinical trial team includes: Sue Oblak, BSN, RN, research study coordinator; and physicians: Medical Director of Peripheral Vascular Intervention Michele DeGregorio, MD; Nishit Choksi, MD; Usman Master, MD; and Kalyana Ramamurthi, MD, co-investigators.
Generally, patients with high blood pressure are treated with medications and advised to make lifestyle changes. However, some patients have a difficult time tolerating the side effects of or are not responding to medications and require another treatment option. These side effects can include: weakness, fatigue, pain, insomnia, rash, dizziness, irregular heartbeat, fever, headaches, diarrhea and heartburn.
The kidneys and renal nerves play a major role in blood pressure regulation. The renal nerves communicate information from the kidney to the brain and vice versa. In people with high blood pressure, the renal nerves are hyperactive, thereby raising blood pressure and possibly damaging the heart, kidney and blood vessels.
RDN is a minimally invasive, catheter-based procedure. A catheter is inserted in the renal arteries, delivering low-power radiofrequency energy that quiets hyperactive nerves that line the walls of the arteries leading to the kidneys, resulting in a possible reduction in blood pressure and protection of the heart, kidney and blood vessels from further damage. The targeted nerves are part of the sympathetic nervous system, which has been found to play a central role in blood pressure regulation.
A total of 530 treatment-resistant hypertension patients are expected to participate in the study.
Eligible subjects will be randomly assigned to one of two groups: a treatment group that will be treated with the RDN procedure or a control group of patients who will not be treated. However, subjects in both groups will continue to take their prescribed blood pressure medications. Subjects will not be told to which group they are assigned and will remain in the hospital overnight for observation, and their medications will not be changed unless medically necessary.
All subjects will be informed of what group they were assigned to six months after the procedure and those that were in the control group will be offered the procedure at that time.
“This is the most exciting study of hypertension in a long time,” said Dr. Patel. “To date, the data has been overwhelmingly positive.”
Heart disease is the leading cause of death among men and women in the U.S. One in three adults or 68 million people have high blood pressure, which is associated with an increased risk of heart attack, stroke, heart failure, kidney disease and death.
Patients who wish to participate in the study:
For information about the study, contact Oblak at 248-858-6962.
About St. Joseph Mercy Oakland
St. Joseph Mercy Oakland is a 443-bed comprehensive, community, teaching hospital and a long-time leader in health care in Oakland County. Founded in 1927 by the Sisters of Mercy, St. Joseph Mercy Oakland has won numerous local and national awards for patient safety, quality and performance, and consistently ranks in the top 10 percent of hospitals nationwide. A member of the Saint Joseph Mercy Health System, St. Joseph Mercy Oakland is a technologically leading hospital that combines advanced medicine and personal care to assist patients on their path to wellness. With dedicated physicians, nurses and hospital staff committed to providing quality care throughout the patient stay, St. Joseph Mercy Oakland has truly personalized the patient care experience.
About Saint Joseph Mercy Health System
Saint Joseph Mercy Health System (SJMHS) is a newly expanded health care organization serving southeast Michigan. Health coverage spans six counties, including Livingston, Macomb, Oakland, St. Clair, Washtenaw and Wayne. It includes 537-bed St. Joseph Mercy in Ann Arbor, 443-bed St. Joseph Mercy Oakland in Pontiac, 304-bed St. Mary Mercy in Livonia, 136-bed St. Joseph Mercy Livingston in Howell, 119-bed St. Joseph Mercy Port Huron, 113-bed Chelsea Community Hospital and 74-bed St. Joseph Mercy Saline. Combined, the seven hospitals are licensed for 1,726 beds, have five outpatient health centers, seven urgent care facilities, more than 25 specialty centers; employ more than 14,000 individuals and have a medical staff of nearly 2,700 physicians.
A member of Trinity Health, the nation’s fourth largest Catholic health care organization, SJMHS is committed to providing a remarkable patient experience by using leading edge technology in a comforting and healing environment. As a mission-based organization, Saint Joseph Mercy Health System provides approximately $100 million in community benefit to the communities it serves each year.