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Effects of continued administration of empagliflozin in patients with heart failure on active SGLT2 inhibitor treatment admitted for acute decompensated heart failure
EU CTIS ID: 2024-517977-26-00
What this study is testing
To assess the non-inferiority of continued administration of empagliflozin 10 mg versus placebo plus standard medical care in patients admitted with acute decompensated heart failure (ADHF) with prior treatment using a SGLT2 inhibitor on the combined endpoint of all-cause mortality, HF hospitalization and worsening renal function at 90 days after admission.
- 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 (age ≥ 18 years) with acute decompensated heart failure (HF) according to clinical assessment on active therapy with a SGLT2 inhibitor
- Brain Natriuretic Peptide (BNP) >100 pg/ml or N-terminal pro-BNP (NT-proBNP) >300 pg/ml
- Written informed consent obtained
- Negative pregnancy test for women of childbearing potential
You likely can't join if
- Type 1 diabetes mellitus
- Identification of any causes of heart failure leading to decompensation that needs urgent management (like acute coronary syndrome, severe unstable arrhythmias, mechanical causes, acute pulmonary embolism)
- Incapacity to understand and / or to provide written informed consent
- Obvious uncontrolled substance abuse
- Pregnancy, breastfeeding
- Chronic Kidney Disease (CKD) with eGFR<20 ml/min, or end-stage renal failure with the need for chronic dialysis treatment
See the full eligibility criteria
- Patients (age ≥ 18 years) with acute decompensated heart failure (HF) according to clinical assessment on active therapy with a SGLT2 inhibitor
- Brain Natriuretic Peptide (BNP) >100 pg/ml or N-terminal pro-BNP (NT-proBNP) >300 pg/ml
- Written informed consent obtained
- Negative pregnancy test for women of childbearing potential
- Type 1 diabetes mellitus
- Identification of any causes of heart failure leading to decompensation that needs urgent management (like acute coronary syndrome, severe unstable arrhythmias, mechanical causes, acute pulmonary embolism)
- Incapacity to understand and / or to provide written informed consent
- Obvious uncontrolled substance abuse
- Pregnancy, breastfeeding
- Chronic Kidney Disease (CKD) with eGFR<20 ml/min, or end-stage renal failure with the need for chronic dialysis treatment
- Acute kidney injury (AKI) requiring dialysis treatment
- Known intolerance to empagliflozin
- Acute heart failure without signs of congestion (“dry” patient)
- Indication for coronary angiography or any foreseeable administration of a contrast media
- Need for hemofiltration or any other form of extracorporeal therapy
- Planned surgery
- Previous participation in this trial or recent participation in another clinical trial (within the last 4 weeks before inclusion)
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, 65+ years, 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.