Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-24 @ 11:19 PM
NCT ID:
NCT07038356
Eligibility Criteria:
Inclusion 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 (NTproBNP) \>300 pg/ml
* Written informed consent obtained
* Women of childbearing potential: negative pregnancy test and use of a highly effective method of contraception
Exclusion Criteria:
* Type 1 diabetes mellitus
* 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)
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07038356
Study Brief:
Protocol Section:
NCT07038356