Phase III Study to Test HRS-1893 Tablets for Treating Obstructive Hypertrophic Cardiomyopathy in Adults

What this Trial Is About

Researchers are evaluating the effectiveness and safety of HRS-1893 tablets in treating patients with obstructive hypertrophic cardiomyopathy, a condition that affects the heart muscle. This Phase III study is sponsored by Shandong Suncadia Medicine Co., Ltd. and aims to assess how well HRS-1893 works compared to a placebo. The study focuses on patients aged 18 to 85 years who meet specific diagnostic and heart function criteria. Participants will be randomly assigned to receive either HRS-1893 tablets or placebo tablets in a double-blind manner, meaning neither the participants nor the researchers know which treatment is given. The treatment period lasts 24 weeks, during which the clinical response rate to HRS-1893 will be evaluated. Secondary outcomes include tracking major heart-related events, adverse effects, and changes in quality of life measured by the Kansas City Cardiomyopathy Questionnaire at weeks 12 and 24. Throughout the study, participants will undergo echocardiographic assessments to monitor heart function and other laboratory tests to ensure safety. They will be closely monitored for any adverse events over approximately 29 weeks. Participants are expected to follow the study protocol strictly and provide informed consent before joining. The total participation time includes treatment and follow-up to evaluate safety and outcomes comprehensively.

A Phase III Trial of HRS-1893 in Patients With Obstructive Hypertrophic Cardiomyopathy