Dapagliflozin and Effect on Cardiovascular Events in Acute Heart Failure -Thrombolysis in Myocardial Infarction 68 (DAPA ACT HF-TIMI 68)

About this Study

This study will test whether the drug dapagliflozin is safe and has beneficial effects when added to conventional heart failure therapy in patients who have been admitted to the hospital for acute heart failure and whose heart is not pumping enough blood with each heartbeat. 

Sponsor Protocol ID:D1699C00004
IRB Number:2020-0163
Actively Enrolling
Phase 4
January 12, 2022
Eligibility Criteria
18 years old
Both Male and Female

Inclusion Criteria
  • Age ≥18 years (male or female)
  • Currently hospitalized for acute heart failure
  • Most recent left ventricular ejection fraction is less than or equal to 40% within the past 12 months
  • Elevated NT-proBNP (greater than or equal to 1600 pg/mL or BNP (greater than or equal to 400 pg/mL) during current hospitalization

Exclusion Criteria
  • Symptomatic hypotension in the past 24 hours
  • Use of an SGLT2 inhibitor within the last 30 days
  • Unable to tolerate SGLT2 inhibitors
  • Type 1 diabetes mellitus or history of diabetic ketoacidosis
  • Implanted cardiac resynchronization therapy (CRT) device or valve repair or replacement within 3 months prior to randomization or intent to do so during the trial
  • History of heart transplantation, current transplant listing, or history of mechanical circulatory support (either durable or temporary)
  • 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
  • History of cirrhosis with evidence of portal hypertension
  • Current participation in a clinical trial with an unlicensed drug or device
  • Women of child-bearing potential (unless using adequate contraception) or currently breastfeeding
  • Study center employees or their family members

Categories Click category to view its trials.
Heart Health
Participating Locations
Pavilion - UMMC
University Heart - UMMC
University Hospital - UMMC
Contact Information
Contact Name: Theresa Hutson
Phone Number: 601-815-8702
Email: thutson@umc.edu
Principal Investigator:Long, Robert C, M.D.
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