SPRINGFIELD -- Over 100 million Americans have hypertension, and more than half of those who are on antihypertensive medications still don't have their blood pressure under control. Doctors at Southern Illinois University Medicine are conducting a groundbreaking clinical trial to test the effectiveness of a new device to lower blood pressure. The CALM-2 study is enrolling participants now.
The CALM-2 clinical study is designed to evaluate an investigational device as a possible solution for patients whose blood pressure is not controlled with prescribed medications. People participating in this study will be among the first in the world to undergo this investigational implant procedure, which is designed to reduce blood pressure after a single treatment. The catheter-delivered MobiusHDŽ device is inserted in the body in a similar way to heart stents. Once in place, it reshapes the carotid artery and triggers the body's "baroreceptors" specialized nerves that send amplified signals to the brain that may lead to long-lasting control of high blood pressure. Vascular Dynamics developed the device and is sponsoring the research.
Individuals who enroll in the study will receive all related care at no cost. SIU Medicine's Springfield location was selected as the first site in the world to randomize a patient. John M. Flack, MD, MPH, professor and chair of SIU's Department of Internal Medicine and president of the American Hypertension Specialist Certification Program, leads the research team. Kim Hodgson, MD, chair of the Division of Vascular Surgery, performed the procedure.
"The impact of high blood pressure on our health is immense," Flack said. "It is the most common reason that patients visit outpatient clinics for treatment. Being part of a clinical research trial gives patients an opportunity to help discover new, safe and effective non-drug treatments for this common but hard-to-manage health concern."
To be a candidate for the study, participants must:
• Be age 18 to 80
• Have systolic blood pressure (the top number) at or above 145 mmHg
• Be taking multiple medications for blood pressure
• Be willing to undergo a minimally invasive procedure for their blood pressure condition and then attend regular follow-up visits over a five-year period
Uncontrolled hypertension increases the risk of heart attack, stroke, long-term damage to the circulatory system, mild cognitive impairment and premature death. This can result in heart failure, kidney failure, sexual dysfunction in men and/or peripheral artery disease. (Find more information at www.Calm2Study.com.)
SIU research teams take part in ongoing, national clinical testing of drugs to treat hypertension and other illnesses to improve individuals' ability to function or improve their quality of life. To learn more about participating in this study, contact Laura Glossop at lglossop74@ siumed.edu or 217-545-7616.