Table 1.

LeoDOR inclusion and selected exclusion criteria

Inclusion criteria

Male and female patients aged >18 years

HF diagnosed at least 6 months before screening and treated with individually optimized long‐term oral and device treatment for the last month, unless not tolerated

LVEF ≤30% as assessed using echocardiography, radionuclide ventriculography, or contrast angiography during the index hospitalization

Currently hospitalized for decompensated HF requiring i.v. diuretics or i.v. vasodilators or i.v. inotropic therapy

Previous hospitalization or visit to an outpatient clinic requiring i.v. diuretics, i.v. vasodilators, or i.v. inotropic therapy for acute decompensated HF within 12 months prior to index hospitalization

NT‐proBNP level (as measured by the local laboratory) after compensation of ≥2500 ng/L and/or NYHA class III or IV at study entry. A compensated status is reached when the patient is haemodynamically stable, euvolemic, established on evidence‐based oral medication, and with stable renal function for at least 24 h

Exclusion criteria

Severe obstruction of ventricular outflow tracts, such as haemodynamically significant uncorrected primary valve disease or hypertrophic cardiomyopathy or impaired ventricular filling, such as restrictive cardiomyopathy

Predominantly right‐sided heart failure and/or severe tricuspid regurgitation

Cardiac surgery or coronary angioplasty within 30 days prior to study drug initiation

Acute coronary syndromes within 30 days prior to study drug initiation

Patients scheduled for cardiac surgery or angioplasty in the next 3 months

History of torsades de pointes

Systolic blood pressure <90 mmHg at baseline

Heart rate ≥120 beats/min at baseline

Serum potassium <3.5 mmol/L before study drug initiation

eGFR ≤30 mL/min/1.73 m2

Administration of levosimendan within 14 days prior to study drug initiation (first study drug application to be postponed for at least 14 days after the end of this premedication)

Hypersensitivity to levosimendan

Other serious diseases that considerably limit life expectancy (e.g. end‐stage cancer, end‐stage renal disease, and end‐stage lung disease)

eGFR, estimated glomerular filtration rate; HF, heart failure; i.v., intravenous; LVEF, left ventricular ejection fraction; NT‐proBNP, N‐terminal pro‐brain natriuretic peptide; NYHA, New York Heart Association.