This study aims to evaluate the safety and effectiveness of Enavogliflozin 0.3 mg, an SGLT2 inhibitor, in patients with amyloid cardiomyopathy. Participants will take both the study drug and a placebo in two separate periods, with a wash-out period in between. The goal is to determine whether Enavogliflozin is safe and effective for treating amyloid cardiomyopathy.
Patients with a confirmed diagnosis of cardiac amyloidosis and symptomatic heart failure (NYHA class II-III) will be recruited. Participants will be randomized to receive either the study drug or placebo and will undergo baseline and 12-week assessments, including the Kansas City Cardiomyopathy Questionnaire (KCCQ), 6-minute walk test, and cardiopulmonary exercise testing. Following a 4-week washout period, participants will cross over to the alternate treatment arm (study drug or placebo) and repeat the same assessments at baseline and 12 weeks. The primary endpoint will be the change in KCCQ Clinical Summary Score (KCCQ-CSS).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
68
Participants will receive Enavogliflozin 0.3 mg orally once daily for 12 weeks. The drug is administered in tablet form and is taken during the first or second treatment period of a crossover design.
Participants will receive placebo orally once daily for 12 weeks. The drug is administered in tablet form and is taken during the first or second treatment period of a crossover design.
Samsung Medical Center
Seoul, South Korea
Seoul St. Mary's Hospital, The Catholic University of Korea
Seoul, South Korea
Change in KCCQ-CSS from baseline to Week 12
Change in the Clinical Summary Score of the Kansas City Cardiomyopathy Questionnaire (KCCQ-CSS) from baseline to 12 weeks after treatment initiation. The KCCQ-CSS is a patient-reported outcome measure that assesses symptom frequency and physical limitation in patients with heart failure. Scores range from 0 to 100, with higher scores indicating better symptom status and physical function (i.e., better health status). A higher change from baseline reflects an improvement in clinical status.
Time frame: Baseline and Week 12
Change in 6-Minute Walk Distance
Change in distance walked in 6 minutes from baseline to Week 12. Higher distance indicates better exercise capacity.
Time frame: Baseline and Week 12
Change in log-transformed NT-proBNP levels
Change in log-transformed NT-proBNP levels after 12 weeks of treatment compared to baseline
Time frame: Baseline and Week 12
Change in Body Weight
Change in body weight in kilograms from baseline to Week 12
Time frame: Baseline and Week 12
Change in Body Fat Percentage
Change in body fat percentage from baseline to Week 12
Time frame: Baseline and Week 12
Change in Extracellular Water Ratio
Change in the ratio of extracellular water to total body water from baseline to Week 12
Time frame: Baseline and Week 12
Incidence of Worsening Heart Failure Events or Death
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Occurrence of worsening heart failure events (defined as emergency outpatient visit or unplanned hospitalization due to heart failure) or death
Time frame: From baseline to Week 12 during each treatment period (excluding the 4-week washout period)