A Multicenter Randomized Double-Blind Parallel Group Placebo-Controlled Trial to Evaluate the Effect of InHospital Initiation of Dapagliflozin on Clinical Outcomes in Patients with Heart Failure with Reduced Ejection Fraction Who Have Been Stabilized During Hospitalization for Acute Heart Failure

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Acute Heart Failure
  • Age: Between 18 - 99 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Male or Female participants who are 18 years old or older
    2. Participants must provide written informed consent
    3. Are currently hospitalized for Acute Heart Failure (AHF)
    4. Participants with most recent LVEF =40% within the past 12 months
    5. Elevated NT-proBNP (=1600 pg/mL) or BNP (=400 pg/mL) during current hospitalization

You may not be eligible for this study if the following are true:

    1. Symptomatic hypotension in the past 24 hours
    2. Use of two or more inotropic agents during the index hospitalization
    3. Those who use sodium-glucose cotransporter-2 (SGLT2) inhibitors or has prior tolerance to SGLT2 inhibitors
    4. Type 1 diabetes mellitus or history of diabetic ketoacidosis
    5. In participants with diabetes on insulin or a sulfonylurea, a history of recurrent major hypoglycemia
    6. Implantation of a cardiac resynchronization therapy (CRT) device or valve repair or replacement during the study
    7. ST-segment elevation myocardial infarction or coronary revascularization
    8. Untreated sustained ventricular arrhythmias or Mobitz type II or third-degree heart block
    9. History of heart transplantation, current transplant listing, or history of mechanical circulatory support (either durable or temporary)
    10. History of heart failure due to restrictive or infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy, uncorrected primary valvular disease, or complex congenital heart disease
    11. History of cirrhosis with evidence of portal hypertension
    12. Women of child-bearing potential (unless using adequate contraception) or currently breastfeeding
    13. Current participation in a clinical trial with an investigational drug or device
    14. Any condition that, in the opinion of the investigator, would make trial participation not in the best interest of the subject, or would compromise compliance with the trial protocol

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