SGLT2 Inhibitors in Transthyretin Amyloid Cardiomyopathy

Exclusion Criteria

• •The presence of any of the following excludes eligibility for enrollment in this study:
• •1. Prior liver or heart transplantation
• •2. Active malignancy or non-amyloid disease with expected survival of less than 1 year
• •3. Heart failure, in the opinion of the investigator, primarily caused by severe left-sided valve disease. Note: if valve was repaired, subject may be considered as no longer with severe valve disease
• •4. Heart failure, in the opinion of the investigator, primarily caused by ischemic heart disease
• •5. Ventricular assist device or anticipated within the next 6 months
• •6. Pacemaker or implantable cardioverter defibrillator incompatible with magnetic resonance technology
• •7. Absolute contraindication for quantitative magnetic resonance (e.g. aneurysmal clips, metal objects)
• •8. Impairment from stroke, injury or other medical disorder that precludes participation in the study
• •9. Myocardial infarction, cardiovascular surgery, stroke or transient ischemic attack within the prior 90 days
• •10. Disabling dementia or other mental or behavioral disease
• •11. Enrollment in a clinical trial not approved for co-enrollment
• •12. Expected use of continuous intravenous inotropic therapy in the next 6 months
• •13. High risk for non-adherence as determined by screening evaluation
• •14. Inability or unwillingness to comply with the study requirements
• •15. Chronic kidney disease with estimated glomerular filtration rate (eGFR) \<15 mL/min/1.73 m2 or end-stage renal disease
• •16. Current or prior SGLT2i use
• •17. Type 1 diabetes mellitus or insulin-dependent diabetes mellitus
• •18. N-terminal (NT)-pro hormone BNP (NT-proBNP) \< 300 pg/mL or \< 900 pg/mL if concomitant diagnosis of atrial fibrillation
• •19. History of ketoacidosis
• •20. History of complex urinary tract or genital infections
• •21. History of kidney stone
• •22. Systolic blood pressure \< 90 mmHg and symptomatic hypotension
• •23. Systolic blood pressure ≥ 180 mmg Hg
• •24. Chronic obstructive pulmonary disease
• •25. Major surgery in the 90 days before or after screening
• •26. Chronic alcohol or drug abuse
• •27. Nursing home resident
• •28. Other reason that would make the subject inappropriate for entry into this study