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).
It is a multicentre, randomized, double-blind, placebo-controlled study. 350 subjects will be included (in 12 or more medical centers) with severe HF, ejection fraction ≤35%, in New York Heart Association class III or IV. The other inclusion criteria concern: hospitalization for the HF decompensation in the last 3 months and a reduced six-minute walk test \<350m or elevated NTproBNP ≥1000 pg / mL. To the European Society of Cardiology-guided, individually optimized medical therapy (OMT) the investigational product (IP) will be added. The subjects will be randomly assigned to one of the study group: 175 to the levosimendan arm and 175 to the placebo arm. The intervention studied in LEIA-HF trial is the administration of levosimendan as a continuous iv. infusion, every 4 weeks for 48 weeks (12 infusions in total). All study participants will also continue OMT. In the second phase of the study, after completing the levosimendan / placebo infusions, another 6 visits are planned, still double-blind, every 4 weeks, to assess the safety of treatment discontinuation (with optional return to the infusions by the Investigator when additional criteria for HF decompensation are met). The efficacy of the treatment will be assessed after 52 weeks, 4 weeks after the last levosimendan / placebo administration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
70
administration of levosimendan as a continuous iv. infusion, every 4 weeks for 48 weeks (12 infusions in total)
administration of glucose as a continuous iv. infusion, every 4 weeks for 48 weeks (12 infusions in total)
Medical University of Bialystok Clinical Hospital
Bialystok, Poland
Medical University Hospital No.1
Bydgoszcz, Poland
Medical University Hospital No.2
Bydgoszcz, Poland
the number of unplanned hospitalization
unplanned hospitalization due to heart failure decompensation
Time frame: 12 months of follow-up period
the number of deaths
death for any cause
Time frame: 12 months of follow-up period
total mortality calculations
total mortality for any cause
Time frame: 0-12, 12-18 and 0-18 months
cardiovascular mortality calculations
mortality due to cardiovascular reasons
Time frame: 0-12, 12-18 and 0-18 months
the number of planned hospitalization
planned hospitalization due to heart failure decompensation
Time frame: 0-12, 12-18 and 0-18 months
the number of implantations of mechanical circulatory support
implantation of mechanical circulatory support
Time frame: 0-12, 12-18 and 0-18 months
the number of heart transplantations
heart transplantation
Time frame: 0-12, 12-18 and 0-18 months
quality of life measurements
The Kansas City Cardiomyopathy Questionnaire quality of life questionnaire- an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
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Uniwersyteckie Centrum Kliniczne
Gdansk, Poland
Górnośląskie Centrum Medyczne Śląskiego Uniwersytetu Medycznego
Katowice, Poland
Szpital Uniwersytecki w Krakowie
Krakow, Poland
John Paul II Hospital
Krakow, Poland
Provincial Specialist Hospital named after Dr. Wł. Biegański
Lodz, Poland
Medical University Hospital
Opole, Poland
University Hospital of Lord's Transfiguration
Poznan, Poland
...and 4 more locations
Time frame: 0-12, 12-18 and 0-18 months
the six-minute walk test
measures the distance an individual is able to walk over a total of six minutes
Time frame: 0-12, 12-18 and 0-18 months
NTproBNP measurements
measurements of NTproBNP concentrations
Time frame: 0-12, 12-18 and 0-18 months
estimated glomerular filtration rate measurements
measurements of estimated glomerular filtration rate
Time frame: 0-12, 12-18 and 0-18 months
echocardiographic parameters
the change in numerous echocardiographic parameters with different units assessed in each patient in transthoracic echocardiographic examination (TTE)
Time frame: 0-12, 12-18 and 0-18 months
patients who returned to levosimendan / placebo infusions
calculations of the percentage of patients who returned to levosimendan / placebo infusions
Time frame: from the 12th to the 18th months of the study