Empagliflozin and Dapagliflozin in Patients Hospitalized for Acute Decompensated Heart Failure

Launched by MEDICAL UNIVERSITY OF WARSAW · Mar 7, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of two medications, Empagliflozin and Dapagliflozin, on patients who are hospitalized for a serious condition called acute decompensated heart failure. This condition means that the heart is not pumping effectively, leading to symptoms such as fluid buildup and shortness of breath. The trial aims to see how these medications can help improve health outcomes for patients in the hospital with this condition.

To participate in the trial, individuals must be at least 18 years old and currently hospitalized for acute decompensated heart failure, regardless of whether they have diabetes. They should be stable and meet specific medical criteria, such as having certain levels of a heart-related blood marker. Participants will be randomly assigned to receive either one of the medications or a placebo (a look-alike pill without active medicine) while continuing their hospital care. This trial is an important step in understanding how these treatments may benefit patients with heart failure.

Gender

ALL

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