Early Treatment With a Sodium-glucose Co-transporter 2 Inhibitor in High-risk Patients With Acute Heart Failure

Exclusion Criteria29

• eGFR \<20 mL/min/1.73m2 at the time of admission
• Already taking an SGLT2i within 3 months prior to hospitalization
• Type 1 diabetes mellitus
• Systolic blood pressure \<90 mmHg
• Expected to newly require treatment with thiazide, tolvaptan, or carperitide within 48 hours of study drug administration
• Main cause of acute heart failure hospitalization is not fluid retention (e.g., persistent ventricular tachycardia, persistent atrial fibrillation/atrial flutter with a ventricular response rate of ≥130 bpm, persistent bradycardia with a ventricular response rate of \<45 bpm, an infection, severe anemia, and an acute exacerbation of COPD)
• Acute coronary syndrome, pulmonary thromboembolism, or a cerebrovascular accident is the main cause of the present hospitalization.
• At risk of ketoacidosis or hyperosmolar hyperglycaemia
• On dialysis, including peritoneal dialysis, or the initiation of dialysis during hospitalization is planned
• Pregnant or lactating women
• Underwent the following therapeutic interventions within 30 days: cardiovascular surgery (e.g., coronary artery bypass grafting, surgery for valvular heart disease, transcatheter aortic valve implantation, percutaneous coronary intervention, percutaneous edge-to-edge mitral valve repair, and other types of surgery at the investigator's discretion) and implantation of an implantable defibrillator, cardiac resynchronization therapy defibrillator, or implantable ventricular-assist device
• A diagnosis of acute coronary syndrome, cerebral infarction, or transient ischemic attack made within 90 days
• Ventricular tachycardia with syncope within 90 days
• Heart transplant recipient or listed for heart transplantation and expected to undergo transplantation during the present treatment; implanted with an implantable ventricular-assist device or expected to require an implantable ventricular-assist device during the present treatment; or expected to switch to palliative care
• Intubated at the time of screening or expected to require intubation within within 48 hours of study drug administration
• Severe valvular heart disease expected to be treated with thoracostomy or catheterization (a reason to exclude secondary mitral or tricuspid regurgitation due to reduced cardiac function does not exist, except for the absence of a plan to perform cardiac surgery or therapeutic catheterization)
• A diagnosis of secondary cardiomyopathy such as amyloidosis, cardiac sarcoidosis, hemochromatosis, Fabry disease, and muscular dystrophy. Heart failure due to takotsubo cardiomyopathy, obstructive hypertrophic cardiomyopathy, complex congenital heart disease (as determined by the investigator), or pericardial constriction.
• A diagnosis of peripartum cardiomyopathy made within 6 months
• Active myocarditis
• Presence of uncontrolled thyroid disease
• Acute cardiac structural abnormalities (e.g., acute mitral regurgitation due to ruptured chordae tendineae)
• Serious liver disorder (an increase in AST, ALT, or ALP level ≥3 times the upper limit of normal) or cirrhosis with varices or other findings suggestive of portal hypertension
• Alcohol use disorder of at least mild severity according to the DSM-V
• A diagnosis of active malignancy or suspected active malignancy made within 2 years
• Coexisting diseases other than heart failure with an expected survival prognosis of ≤1 year
• Participation in a clinical study of another drug 30 days before hospitalization
• Patients considered to require fasting at screening.
• Other conditions likely to interfere with the patient's safety or compliance with the protocol
• Other patients who are considered unsuitable by the principal investigator or other investigators