Empagliflozin and Dapagliflozin in Patients Hospitalized for Acute Decompensated Heart Failure

• Status: Recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Warsaw
• Collaborators: Autonomous Public Specialist Western John Paul II Hospital in Grodzisk Mazowiecki; Jerzy Popiełuszko Bielański Hospital in Warsaw; John Paul II Specialist Hospital in Kraków; Ludwik Rydygier Regional Polyclinical Hospital in Toruń; Medical University of Gdańsk; Medical University of Graz; Medical University of Silesia in Katowice; Medical University of Vienna; Nicolaus Copernicus University in Toruń, Collegium Medicum in Bydgoszcz; Poznan University of Medical Sciences; Regional Polyclinical Hospital in Kielce; University Clinical Center of the Medical University of Warsaw; University Clinical Hospital Military Medical Academy, Central Veterans Hospital in Łódź; University Teaching Hospital in Białystok
• Treatments: Dapagliflozin; Empagliflozin; Sodium-Glucose Transporter 2 Inhibitors

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