Empagliflozin and Dapagliflozin in Patients Hospitalized for Acute Decompensated Heart Failure (EMPATHY)

Medical University of Warsaw

Status and phase: Enrolling; Phase 3

Conditions: Acute Decompensated Heart Failure

Treatments: Drug: Dapagliflozin 10 MG; Drug: Empagliflozin 10 MG; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05776043

EMPATHY

2019/ABM/01/00037 (Other Grant/Funding Number)

2020-003497-48 (EudraCT Number)

Details and patient eligibility

About

National, multicenter, randomized, double-blind, parallel-group, stratified by SGLT-2 inhibitor type, placebo-controlled trial, - a Phase III study. Primary objective of the study is to investigate the impact of SGLT-2 inhibitors (Empagliflozin and Dapagliflozin) on clinical endpoints in patients hospitalized with acute/decompensated HF.

Enrollment: 1,364 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,364 participants in 2 patient groups, including a placebo group

SGLT 2 Inhibitor

Active Comparator group

Description:

Empagliflozin (n=341) or Dapagliflozin (n=341): 9 months of treatment

Treatment:

Drug: Empagliflozin 10 MG

Drug: Dapagliflozin 10 MG

Placebo with a switch to SGLT 2 Inhibitor

Placebo Comparator group

Description:

Placebo (n=682) for 3 months of treatment with a subsequent switch to Empagliflozin (n=341) or Dapagliflozin (n=341): 6 months of treatment

Treatment:

Drug: Placebo