Multi-center Prospective Study to Track Real-World Safety, Clinical Effectiveness, and Healthcare Resource Impact of MYQORZO in Routine Clinical Practice
SOUTH SAN FRANCISCO, Calif., Sept. 30, 2026 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced the start of ASPEN-HCM (Aficamten Study of Patient Experience and Novel Outcomes in Symptomatic Obstructive HCM), a prospective, multicenter, observational real-world study evaluating MYQORZO® (aficamten) in adult patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). MYQORZO is a once-daily, oral allosteric and reversible inhibitor of cardiac myosin motor activity. In patients with oHCM, myosin inhibition with MYQORZO reduces cardiac contractility and left ventricular outflow tract (LVOT) obstruction.
“We are pleased to announce the start of ASPEN-HCM, marking an important next step in our ongoing commitment to hypertrophic cardiomyopathy research,” said Sanatan Shreay, Ph.D., Cytokinetics’ Executive Director, Head of Health Economics and Outcomes Research. “The clinical trials we conducted of MYQORZO provided strong evidence supporting its approval. Now, this study will build on that foundation by generating valuable real-world insights that can help inform clinical decision-making and support clinicians in their everyday practices.”
Led by the University of California, San Francisco (UCSF), ASPEN-HCM will evaluate the safety and effectiveness of MYQORZO in routine clinical practice to generate prospective, real-world evidence on the clinical and economic impact of treatment.
“With our deep commitment to driving innovation in cardiology, this important study is designed to provide critical insights about the impact of the latest non-invasive treatment in HCM, the most common inherited heart disease,” said Theodore Abraham, M.D., co-director, UCSF HCM Center of Excellence.
ASPEN-HCM: Study Design
This prospective, multicenter, observational real-world study is designed to evaluate the clinical, economic, and patient impact of MYQORZO in adult patients with oHCM across 13 cardiology practices and HCM centers of excellence. Over an anticipated 12-to-36-month period, the study aims to enroll approximately 400 patients to characterize the real-world safety profile of MYQORZO.
The study will evaluate real-world safety and effectiveness outcomes, including reductions in left ventricular ejection fraction (LVEF), treatment discontinuations, changes in in left ventricular outflow tract gradient (LVOT–G), New York Heart Association (NYHA) classification, and patient-reported outcomes.
Secondary study objectives focus on analyzing healthcare resource utilization, conducting pre-and-post economic analyses on hospitalization and procedure rates, and tracking cardiac structural remodeling using parameters like left ventricular mass index and septal thickness.
Additionally, the study will investigate longitudinal treatment patterns, dose titration pathways, the prevalence and incidence of atrial fibrillation, potential predictors of treatment response, and the clinical impact of MYQORZO on avoiding or delaying invasive septal reduction therapy.
To learn more about ASPEN-HCM, visit www.clinicaltrials.gov.
The full U.S. Prescribing Information for MYQORZO includes a Boxed WARNING for the risk of heart failure. MYQORZO reduces left ventricular ejection fraction (LVEF) and can cause heart failure due to systolic dysfunction. Echocardiogram assessments are required prior to and during treatment with MYQORZO to monitor for systolic dysfunction. Initiation of MYQORZO in patients LVEF