Enavogliflozin for the Management of Patients With Amyloid CardiomyopaThy

Korábbi kezelés

• Scheduled for coronary revascularization, CRT-D implantation, atrial flutter/fibrillation ablation, or valve surgery
• Major surgery within 90 days prior to enrollment
• Unable to understand or comply with study drug, procedures, or follow-up, or who are deemed by the investigator to be unlikely to complete the study

Más betegség

• Active infection
• Major cardiovascular events (e.g., myocardial infarction, stroke) within the past 6 months
• History of heart transplantation
• No history of cancer within the past 5 years at screening (except borderline cancers without recurrence for 2-3 years; multiple myeloma with cardiac involvement is classified as cardiac amyloidosis and is exempt)
• Heart failure primarily caused by severe left sided valvular disease or ischemic heart disease (except if valvular disease is corrected)
• Type 1 diabetes mellitus or insulin-dependent diabetes
• History of ketoacidosis, complicated urinary or genital infections, or kidney stones
• Known hypersensitivity or allergic reaction to the study drug or its components
• Moderate to severe liver impairment

Laborértékek

• Estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73 m² (calculated by CKD-EPI formula)

Egyéb

• Pregnant or breastfeeding women
• Systolic blood pressure < 80 mmHg or symptomatic hypotension
• Chronic alcohol or substance abuse
• Residing in long-term care facilities (e.g., nursing homes)

• Adults aged 19 years or older
• Diagnosed with amyloid cardiomyopathy confirmed by cardiac biopsy or non-invasive imaging
• Presence of heart failure symptoms corresponding to NYHA functional class II-III
• Patients on stable oral diuretic use, without dose changes exceeding 50% of the previous dose, for at least 2 weeks prior to study enrollment
• Ambulatory (able to walk)
• Able to provide written informed consent for study participation