acute decompensated heart failure MedDRA version: 20.0 Level: LLT Classification code 10000803 Term: Acute heart failure System Organ Class: 100000004849
Conditions
Sponsors
Friedrich Schiller University Jena
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients (between 18 - 85 years) with acute decompensated heart failure (HF). • Brain Natriuretic Peptide (BNP) >100 pg/ml, or N-terminal pro-BNP (NT-proBNP)>300 pg/ml as defined by current clinical guidelines for the diagnosis of acute decompensated HF (European Society of Cardiology 2016 HF guideline) • Patients with diabetes mellitus type 2 or impaired glucose tolerance as defined by current clinical guidelines (German and International Diabetes Society 2016: HbA1c>6.5 % (upper limit for this clinical Trial 12%) or fasting glucose >7.0 mmol/l or any incidental glucose level >11.1 mmol/l or abnormal oral glucose tolerance test with 2h plasma glucose >7.8 mmol/l) or on antidiabetic medication or antidiabetic diet or patients with normal glucose tolerance • Patients without cognitive impairment, i.e. they must be capable of understanding the nature, significance and implications of the clinical trial and to form a rational intention in the light of the Facts • Written informed consent obtained • For women with childbearing potential (until 2 years after menopause): o Negative pregnancy test o regular and correct use of a highly effective contraceptive method with an error rate of =65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: • Type 1 diabetes mellitus • Chronic Kidney Disease (CKD) with eGFR< 30 ml/min (if obviously not related to acute kidney injury), or end-stage renal failure with the need for chronic dialysis treatment • Acute kidney injury (AKI) =AKIN stage 2 or requiring dialysis treatment • Current medication with SGLT-2 inhibitors • Known intolerance or hypersensitivity to the active substance empagliflozin, lactose or any other of the excipients listed in section 6.1. of the SmPC • A contraindication or intolerance to furosemide • Acute heart failure without signs of congestion (“dry” patient) •Indication for urgent coronary angiography or planned administration of a iodine based contrast agent within the next 6 days. • Need for hemofiltration or any other form of extracorporeal therapy • Planned surgery • Recent participation in another clinical trial (within the last 3 months before inclusion, so that medical product/s from previous trial participation/s have been fully washed out ) • 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 • Ongoing reported alcohol abuse (daily alcohol intake of more than 2 drinks (liquor, beer or wine) in men and 1 drink in women, corresponding to 12/24 g of pure alcohol per day women / men and/ or obvious alcoholisation of the patient during screening )
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of empagliflozin plus loop diuretics versus placebo plus loop diuretics in patients with ADHF on the increase of urine output ;Secondary Objective: To evaluate the effects of empagliflozin plus loop diuretics versus placebo plus loop diuretics in patients with ADHF, in terms of renal function, length of hospital stay, quality of life, insulin resistance and the need for further administration of diuretics;Primary end point(s): Total urine output as measured by daily volume summed up over 5 days ;Timepoint(s) of evaluation of this end point: after 5 days of therapy with Empaglifozin | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Daily urine volume measured over 5 days • Renal function under treatment • Increase in serum creatinine of >0.3 mg/dl • Doubling of serum creatinine • Need for renal replacement therapy • Net fluid output • Total urinary sodium excretion • Fractional excretion of sodium • Change of insulin resistance (Homa-IR) • Cumulative dosage of diuretics and diuretics efficiency by net urinary output (UOP) in ml/mg furosemide and total daily UOP in ml/mg furosemide • Change in body weight from baseline to 72 hours • Duration of IV furosemide • Additional ADHF therapy • Severity of HF (Symptombasierter Kurzfragebogen ) • Severity of dyspnea (NYHA class) • Peripheral oedema (per clinical judgement) • Elevated jugular venous pulse pressure • Quality of life (EQ-5D-3L) • Change in NT-proBNP at 72 hr • Worsening or persistent heart failure • IMC / ICU and hospital length of stay • Liver function (bilirubin, serum aminotransferases, relevant change in coagulation status) • Pulmonary function: oxygen saturation without oxygen therapy/ need for oxygen in l/min, presence of rales, changes in chest x-ray (worsening/ improvement/ new infiltration) • Number of patients alive and out of hospital -after 30 days ;Timepoint(s) of evaluation of this end point: different timepoints until day 5 after randomisation, hospital discharge and at follow-up visit day 30 after randomisation | — |
Countries
Germany
Contacts
Public ContactCenter for Clinical Studies
Universitätsklinikum Jena, Zentrum für Klinische Studien
Outcome results
None listed