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Mercy Research’s non-oncology team is committed to offering alternative treatments to our patients through the exploration of new drug therapies and development of new medical devices. We believe health care challenges can be mitigated with purposeful, quality clinical trial research opportunities and strive to make these available to Mercy patients and their caregivers in many therapeutic categories and in all our Mercy communities.
We offer clinical trials in most specialty areas, including ophthalmology, cardiology, neurology, multiple sclerosis, gastroenterology, endocrinology, infectious disease, vascular, orthopedics, pediatrics, burn, trauma, pain management and more.
Clinical studies offer our patients earlier access to potentially beneficial new treatments, frequent monitoring through more visits with the provider, active participation in their own care, participation in medical breakthroughs, more options and more hope.
Virtual technologies are transforming the way clinical trials are conducted. In these virtual (or decentralized) studies, wearable devices, smartphone apps and other technologies are making it possible to participate in clinical studies from any location.
Patients with chronic heart failure, with or without type 2 diabetes (T2D), can participate in a pharmaceutical study using a smartphone app and a wearable device. The CHIEF-HF study is evaluating an investigational medication for the management of heart failure.
Study medication and a wearable device will be shipped directly to study participants who enroll via a smartphone app. Once enrolled, they use the app to answer questionnaires at various intervals and to log their medication compliance. The wearable device will collect actigraphy (rest/activity cycle) data, including daily steps and floors climbed. Activity changes will be measured over the study period. All contact with study participants will be virtual, eliminating the need for inperson visits.
Participants will be randomized to take investigational medication or a placebo with their usual medications for three months. At the end of the 3 months, they’ll continue wearing the device and answering the questionnaires at various intervals for another 6 months. The total length of participation in the study is 9 months.
For additional trial information, visit clinicaltrials.gov, and search NCT number 04252287.
Baroreflex Activation Therapy for Heart Failure (BeAT-HF) Trial
About 6.5 million Americans live with heart failure—a condition in which the heart muscle can’t pump enough blood to meet the body’s needs. As the disease progresses, standard treatments may become less effective. Mercy Research participated in the BeAT-HF trial to test a device that uses the brain and nervous system to treat patients with advanced heart failure.
Dr. Shang-Chiun Lee of Mercy Clinic Cardiology in Springfield and Dr. Kaled Awad of Mercy Clinic Heart and Vascular in St. Louis evaluated the effectiveness of the BAROSTIM NEO™ device in heart failure patients who weren’t candidates for biventricular pacemakers. The BAROSTIM NEO™ stimulates baroreceptors (cells in the arteries of the neck) to trigger the body’s natural hormone systems, which regulates blood flow, lowers blood pressure and improves heart function.
Early study results show the BAROSTIM NEO™ reduces heart failure symptoms, increases patients’ exercise tolerance and improves other quality of life measures. The device remains under clinical evaluation, but electrophysiology researchers like Dr. Lee are optimistic about its potential.
“Neurohormonal modulation is key to treating advanced heart failure. It can be delivered safely with devices like the BAROSTIM NEO™, so this is a step in the right direction,” Dr. Lee says.
For additional trial information, visit clinicaltrials.gov using NCT number 02627196.
Efficacy and Safety of Erenumab in Pediatric Subjects with Episodic Migraine (OASIS EM) and Chronic Migraine (OASIS CM)
Migraines are often thought of as an adult condition, but they’re common in adolescents as well. Approximately 10-20% of adolescents experience migraines, and many have already tried the available preventive medications without success. Mercy Research is participating in two trials to determine if Erenumab—a medication with proven results in adults—can be used to safely and effectively treat adolescent migraines.
Dr. Jo Bonner of Mercy Neurology in St. Louis, the principal investigator for the OASIS EM and CM trials, says Erenumab is a more targeted migraine treatment. “Other medications were developed to treat conditions like high blood pressure, seizures and depression. Erenumab specifically targets the migraine process,” she says. Erenumab blocks the receptor (signaling pathway) of calcitonin gene-related peptide (CGRP), a molecule in the neurons that affects migraines.
Study participants are adolescents age 12-17 who have either episodic migraines (four to 14 headache days per month) or chronic migraines (15 or more headache days per month, including eight migraines). They receive monthly injections of Erenumab or a placebo for the first six months; patients are blinded to the type of intervention they receive. This is followed by an open-label trial, which means all participants receive Erenumab. Both the episodic and chronic migraine trials are currently enrolling adolescents.
For additional trial information, visit clinicaltrials.gov using NCT numbers 03836040 (OASIS EM) and 03832998 (OASIS CM).
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