A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of SOtaglifloziN in symptomATic obstructive And non-obstructive Hypertrophic CardioMyopathy (SONATA-HCM)



Hypertrophic cardiomyopathy (HCM) is a common heart condition that can trigger sudden death, irregular heartbeats, and heart failure. The condition is linked to genes and causes the heart muscle to thicken, which impacts how your heart functions. The study drug, sotagliflozin, controls blood sugar by slowing gut absorption and boosting helpful hormones. In the kidneys, it blocks glucose (blood sugar), leading to calorie loss and potentially lowering blood pressure. This might indirectly ease heart stress. Thus, it can potentially be used for HCM treatment. The purposes of this study are: to determine if the study drug is effective in treating symptoms related to HCM; to determine how well the study drug is tolerated and whether there are any side effects to this study drug. Sotagliflozin is approved by the United States Food and Drug Administration (FDA) for a heart failure related indication; however, it is considered as an experimental drug in this study, which means it has not yet been approved as a treatment for HCM in the United States and is not currently available for prescription for treating HCM.

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