Stopped: The level of recruitment, 62 participants enrolled, does not allow for achieving the protocol-defined target of 350 participants by the end of the recruitment period.
Poland70 participantsStarted 2021-12-15
Plain-language summary
The objective of the study is to determine the efficacy of repeated infusions of levosimendan in the group of outpatients with advanced systolic heart failure (HF).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Informed consent obtained before any trial activities
* Male or female, age ≥ 18 years at the time of signing informed consent
* Left ventricle ejection fraction ≤ 35%
* Hospitalization due to worsening of HF within the last 3 months
* New York Heart Association functional class III or outpatient IV
* Individually optimized pharmacotherapy, based on the current European Society of Cardiology recommendations, stable for at least 1 month prior to randomization, according to the knowledge and experience of the qualifying clinician
* Distance covered in six-minute walk test \<350m OR NTproBNP concentration ≥ 1000 pg/mL
* In the opinion of the Investigator, the patient does not currently require hospitalization
* Patient protected with an implantable device capable of terminating life-threatening arrhythmias and conduction disturbances (ICD or cardiac resynchronisation therapy-D/P), if indicated and the patient consents to implantation.
Exclusion Criteria:
* Known or suspected hypersensitivity to trial products or related products,
* Restrictive or hypertrophic cardiomyopathy, uncorrected severe valvular disease, potentially reversible cause of HF
* Hypotension with symptoms of tissue hypoperfusion
* Uncontrolled hypertension
* Planned revascularization or other surgical treatment of HF within the next year
* Advanced chronic kidney disease
* Features of liver damage
* Severe chronic lung disease with features of respiratory distress or severe abnormal spi…