A Study to Test Dapagliflozin in Patients with Acute Heart Failure

A Study to Test Dapagliflozin in Patients with Acute Heart Failure

Patients with or without type 2 diabetes who are hospitalized with ADHF regardless of left ventricular ejection fraction (LVEF) will be randomly assigned to either to protocoled furosemide (40 mg intravenously) plus placebo or they will be received furosemide plus 10 mg of dapagliflozin daily. The duration of treatment will be 5 days in both groups; ejection fraction and serum level of sirtuin will be measured on day5. After that, patients in the control group will receive conventional treatments plus placebo, and in the test group, they will receive conventional treatments plus 10 mg dapagliflozin daily for 8 weeks. After the completion of the treatment, the patients of the two groups will be compared for amount of edema, heart function, serum level of BNP, urine volume, rate of referral to the cardiac care unit, and death.

A double-blind and randomized study which will be performed in Semnan Kowsar Hospital and Tehran Shahid Rajai Hospital.

Inclusion criteria: Patients (age between 20-80 years) with acute decompensated heart failure (ADHF). Brain Natriuretic Peptide (BNP) >100 pg/ml, or N-terminal pro-BNP (NT-proBNP)>300 pg/ml  with evidence of congestion Exclusion criteria: Type 1 diabetes Serum glucose < 80 mg/dL Systolic blood pressure < 90 mmHg Requirement of inotropic therapy History of hypersensitivity to SGLT-2 inhibitors Already receiving an SGLT2 inhibitor Pregnancy History of diabetic ketoacidosis Acute heart failure without signs of congestion ("dry" patient) Acute myocardial infarction

Control group: IV furosemide plus placebo Intervention group: IV furosemide plus 10 mg oral dapagliflozin

Ejection fraction

The method of randomly assigning people in two groups is permuted block randomization. In this method, A will represent group one (protocol treatment of furosemide with the addition of dapagliflozin 10 mg per day) and B will represent group two (furosemide plus placebo). In this way, the order of interventions A and B in the form of 5 blocks of 8 and 5 blocks of 12 from number 1 to 10 is determined by the methodological consultant of the project and placed at the disposal of the executive supervisor of the project.The executive supervisor selects one of the numbers 0 to 9 (1 to 9 blocks number 1 to 9 and zero is a sign for block number 10) using a table of random numbers, and then the qualified people according to the predetermined (from left to right) are attributed to one of two groups A or B. It should be mentioned in case of crossed consequences, another number (between 0 and 9) will be selected for such person.

After signing the consent letter, patients will be entered either in control or intervention group. Included patients are not aware of receiving placebo or the test drug. In addition, physicians and the department staff are blinded from patients allocation.