Dapagliflozin at Discharge on Hospital Heart Failure Readmission (NCT04249778) | Clinical Trial Compass
CompletedPhase 4
Dapagliflozin at Discharge on Hospital Heart Failure Readmission
United States105 participantsStarted 2020-07-29
Plain-language summary
This study will evaluate the safety and efficacy of dapagliflozin treatment in preventing hospital re-admissions, emergency room (ER) visits, urgent clinic visits, and death in patients with and without type 2 diabetes (T2D) after hospital admission for heart failure.
Who can participate
Age range18 Years – 90 Years
SexALL
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Inclusion criteria
✓. Males or females between the ages of 18 and 90 years, with ADHF, and New York Heart Association (NYHA) class II, III, or IV symptoms discharged after hospital admission with a clinical diagnosis ADHF
✓. Elevated natriuretic peptide tests measure levels of BNP (NT-pro-BNP) ≥300 pg/ml or B-type natriuretic peptide (BNP) ≥100 pg/ml on admission
✓. Interpretable echocardiogram during hospital admission (or within 12 months prior to index hospitalization)
✓. Blood glucose level \<400 mg/dL without evidence of diabetic ketoacidosis (serum bicarbonate \<18 milliequivalent (mEq)/L or positive serum or urinary ketones), in patients with T2D
Exclusion criteria
✕. Age \< 18 or \> 90 years
✕. Subjects with a history of type 1 diabetes
✕. Treatment with thiazolidinediones (TZDs) or SGLT2-i during the past 3 months of admission
✕. Recurrent episodes of severe hypoglycemia or hypoglycemic unawareness
✕. History of recurrent HF admissions considered to be due to non-compliance (evaluated by the research staff for participation)
✕. Patients with clinically significant hepatic disease (cirrhosis, jaundice, end-stage liver disease, portal hypertension) and elevated alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \> 3 times upper limit of normal
✕
What they're measuring
1
Number of Participants With Hospital Admissions, Emergency Department Visits, Urgent Clinic Visits, and Death