Aurora St. Luke’s Medical Center in Milwaukee is the first site in Wisconsin to join a clinical trial evaluating whether an investigational drug could be the first treatment to delay the progression of aortic stenosis, one of the most common types of valvular heart disease.
Aortic stenosis is a narrowing of the opening controlled by the heart’s aortic valve, which helps move oxygenated blood out of the heart and toward the body. The smaller opening reduces the amount of blood able to leave the heart, resulting in decreased oxygen delivery to the body and an increased blood pressure in the heart. If left untreated, aortic stenosis can lead to heart failure.
“The cause of aortic stenosis is a progressive thickening and hardening, or calcification, of the aortic valve, which restricts its ability to fully open,” said interventional cardiologist M. Fuad Jan, MD, Advocate Aurora Research Institute’s principal investigator for the study. “Right now, the only treatment is aortic valve replacement through surgery. There is currently no way to slow down aortic valve calcification, which is why the possibility of a potential drug treatment is so exciting.”
The clinical trial, known as EVOID-AS, will gauge the safety and effectiveness of the study drug, Evogliptin, compared to placebo in reducing the progression of aortic valve calcification in people with calcific aortic valve disease with mild to moderate aortic stenosis. Calcification is measured using a computed tomography, or CT, scan. Evogliptin is used to treat diabetes in other parts of the world but is not approved for use in the U.S. outside of a clinical trial.
Aortic stenosis can sometimes result from a birth defect in the heart but more commonly develops through the natural aging process. About 5% of people ages 65 and older and about 10% of people ages 80 and older have aortic stenosis. Symptoms include chest pain, a rapid or fluttering heartbeat, shortness of breath, dizziness or fainting, difficulty walking short distances or performing normal activities, swollen ankles, and difficulty sleeping.
“Aortic stenosis is a growing public health problem, making research into potential treatments vitally important,” said Laura Wrona, MSN, director of the Research Institute’s Center for Excellence in Cardiovascular Research. “With the number of Americans ages 65 and older expected to nearly double by midcentury, rates of aortic stenosis could increase exponentially.”
Researchers plan to enroll nearly 900 participants in the study, “A study to evaluate the efficacy and safety of DA-1229 (Evogliptin) in patient's calcific aortic valve disease with mild to moderate aortic stenosis (EVOID-AS),” which is sponsored by REDNVIA Co., Ltd., manufacturer of Evogliptin.
To learn more about Advocate Aurora’s research, visit aah.org/research.
About Advocate Aurora Research Institute
Advocate Aurora Research Institute is a not-for-profit, limited liability company of Advocate Aurora Health. Advocate Aurora has emerged as a national destination for patient-centered bench, translational and clinical research, and the Research Institute unifies the innovative research efforts throughout the health system. Advocate Aurora researchers focus on rapidly translating new discoveries from the scientist’s bench to the patient’s bedside and into the community we serve to improve options and outcomes that change not only the lives of individuals, but transform the health of populations.