Estimated 1,400 patients to be enrolled from 100 sites worldwide
Calcification of the aortic valve is the leading cause of heart valve disease in older adults, but no approved medications are available to slow its progression, the Sarasota Memorial Hospital (SMH) staff points out in a recent news release. SMH’s “Kolschowsky Research and Education Institute is working to change that,” the release says.
“The new KATALYST-AV trial,” sponsored by Kardigan Inc., “aims to evaluate whether the investigational medication Ataciguat can slow the buildup of calcium in the aortic valve in adults with moderate calcific aortic valve stenosis (CAVS),” the release explains.
Led at SMH by interventional cardiologist Dr. Ricardo Yaryura, the study also will “assess the safety, tolerability and metabolism of the medication — how it is processed in the body,” the release adds.
“The phase 3 clinical study will enroll an estimated 1,400 patients across approximately 100 sites worldwide,” the release continues. “If proven safe and effective, Ataciguat could become the first pharmacologic therapy to slow the progression of aortic valve calcium deposition in adults with CAVS,” it notes.
To be eligible for the trial, participants must be 50 years of age or older, “have a confirmed diagnosis of moderate calcific aortic valve stenosis, and must not have had any prior aortic valve replacement, repair, or other intervention,” the release points out.
“For more information or to find out if you are eligible to participate in the local study,” contact the research team at 941-917-2225 or email researchinstitute@smh.com. For information about the national trial, visit https://clinicaltrials.gov/study/NCT07001800.
“Located on the flagship Sarasota Memorial Hospital-Sarasota campus, the Kolschowsky Research and Education Institute serves as a premier hub for medical research and clinical innovation,” the release explains. “With dedicated space for research, clinical innovation and graduate medical education, the Kolschowsky Institute provides a collaborative learning environment for physicians, nurses, researchers and students studying new treatments and mastering the latest tools and techniques in patient care,” the release says. For information, visit https://www.smh.com/Home/Services/Kolschowsky-Research-and-Education-Institute.