Empagliflozin and Dapagliflozin in Patients Hospitalized for Acute Decompensated Heart Failure (EMPATHY)
Acute Decompensated Heart Failure
About this trial
This is an interventional treatment trial for Acute Decompensated Heart Failure focused on measuring SGLT-2 inhibitors, dapagliflozin, empagliflozin, acute heart failure, decompensated heart failure
Eligibility Criteria
Inclusion Criteria: Patients 18 years of age with the capacity to provide written informed consent Currently hospitalized for a primary diagnosis of acute/decompensated HF (HFrEF, HFmrEF,HFpEF), including symptoms and signs of fluid overload regardless of ejection fraction or diabetes status In patients with HFpEF the diagnosis has to be confirmed according to the current HFpEF definition (by non-invasive testing: evidence of structural or functional changes in the heart as evidenced on echocardiography or by invasive testing as LVEDP assessment or right heart catheterisation). Randomized no earlier than 24 hours and up to 10 days after initial presentation while still hospitalized Stable as defined by: systolic blood pressure (SBP>100 mmHg for the preceding 6 hours) No intensification of IV diuretics within the last 6 hours, No use of IV vasodilators within the last 6 hours, No use of IV inotropes or levosimendan within the last 24 hours prior to randomization Elevated NT-proBNP >600 pg/mL during the current hospitalization in patients with HFrEF and >300 pg/mL in patients with HFmrEF or HFpEF (or above 900 pg/ml if atrial fibrillation is present at admission independently from EF). eGFR >20 ml/min/1,73m2 Exclusion Criteria: History of ketoacidosis Type 1 diabetes SGLT-2 Inhibitor at baseline or known allergy to SGLT-2 Inhibitors Current active cancer with less than 2 years of life expectancy Pulmonary embolism, cerebrovascular accident as the primary trigger for the current hospitalization Cardiomyopathy based on infiltrative diseases (e.g. amyloidosis), accumulation diseases (e.g. haemochromatosis, Fabry disease), muscular dystrophies, cardiomyopathy with reversible causes (e.g. stress cardiomyopathy), hypertrophic obstructive cardiomyopathy or known pericardial constriction Any severe (obstructive or regurgitant) valvular heart disease, expected to lead to surgery during the trial period Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant Blood pH<7.32 >1 episode of severe hypoglycaemia within the last 6 months under treatment with insulin or sulfonylurea Acute symptomatic urinary tract infection or genital infection
Sites / Locations
- Autonomous Public Specialist Western John Paul II HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
SGLT 2 Inhibitor
Placebo with a switch to SGLT 2 Inhibitor
Empagliflozin (n=341) or Dapagliflozin (n=341): 9 months of treatment
Placebo (n=682) for 3 months of treatment with a subsequent switch to Empagliflozin (n=341) or Dapagliflozin (n=341): 6 months of treatment