Evaluating Enavogliflozin 0.3 mg for Treating Amyloid Cardiomyopathy in Adults A Randomized, Double-Blind, Placebo-Controlled Crossover Study

What this Trial Is About

Researchers are evaluating the safety and effectiveness of Enavogliflozin 0.3 mg, a drug called an SGLT2 inhibitor, in adults with amyloid cardiomyopathy who also have symptoms of heart failure. This phase 4 study uses a crossover design where participants receive both the study drug and a placebo in two separate treatment periods. The goal is to see if Enavogliflozin is safe and helpful for managing amyloid cardiomyopathy symptoms. Participants will be randomly assigned to take either Enavogliflozin or a placebo orally once daily for 12 weeks during the first treatment period. After a 4-week washout break, they will switch to the other treatment for another 12 weeks. During both treatment periods, participants will undergo assessments including the Kansas City Cardiomyopathy Questionnaire, a 6-minute walk test, and cardiopulmonary exercise testing. Throughout the study, participants will have baseline and 12-week evaluations for each treatment period. Researchers will measure changes in heart failure symptoms using the KCCQ Clinical Summary Score as the main outcome. Additional measures include walking distance, blood markers, body composition, and heart failure events. The study involves careful monitoring and lasts until the completion of both treatment phases and follow-up, with a total duration covering these periods and assessments.

Enavogliflozin for the Management of Patients With Amyloid CardiomyopaThy