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Empagliflozin and dapagliflozin for improvement of outcome in patients with acute heart failure
EU CTIS ID: 2024-518685-27-00
What this study is testing
The primary objective is to investigate and compare the impact of SGLT-2 inhibitors (Empagliflozin and Dapagliflozin) on primary and secondary clinical endpoints in patients hospitalized due to acute/decompensated HF regardless of ejection fraction (HFrEF, HFmEF, HFpEF) or diabetes status.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients 18 years of age with the capacity to provide written informed consent
- eGFR >20 ml/min/1,73m2
- 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)
You likely can't join if
- History of ketoacidosis
- >1 episode of severe hypoglycaemia within the last 6 months under treatment with insulin or sulfonylurea
- Acute symptomatic urinary tract infection or genital infection
- 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
See the full eligibility criteria
- Patients 18 years of age with the capacity to provide written informed consent
- eGFR >20 ml/min/1,73m2
- 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).
- History of ketoacidosis
- >1 episode of severe hypoglycaemia within the last 6 months under treatment with insulin or sulfonylurea
- Acute symptomatic urinary tract infection or genital infection
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.