Repetitive levosimendan infusions for patients with advanced chronic heart failure (LeoDOR) A randomised, double-blind, placebo-controlled multicentre study with parallel group design. Mortality and rehospitalisation rates are high in the vulnerable phase following heart failure hospitalisation. Previous studies suggest that these events can be reduced by repeat infusions of levosimendan in patients with advanced heart failure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
264
Levosimendan Arm: 1 x 5 ml (1 vial) of levosimendan infusion concentrate is added to one 250 ml infusion bag of 5% glucose or 0.9% NaCl in diabetic patients.
Placebo Arm: 1 x 5 ml (1 vial) of placebo levosimendan infusion concentrate is added to one 250 ml infusion bag of 5% glucose or 0.9% NaCl in diabetic patients.
Medical University Innsbruck
Innsbruck, Tyrol, Austria
RECRUITINGTime to death, high-urgent heart transplantation or ventricular assist device (VAD), time to non-fatal HF event
Time to event in days, from baseline visit (day 1) up to Follow-up 2 (day 180)
Time frame: From baseline (day 1) up to Follow-up 2 (day 180)
Change in NT-proBNP
pg/ml
Time frame: Change from Baseline NT-proBNP (day 1) to Follow-up 1 (day 90)
Change in functional status and symptoms via KCCQ (Combined Outcome measurement)
KCCQ (Kansas City Cardiomyopathy Questionnaire) The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.
Time frame: From baseline (day 1) up to day 98 (FUP 1)
Change in functional status and symptoms via PGA (Combined Outcome measurement)
PGA (Patient's global assessment)
Time frame: From baseline (day 1) up to day 98 (FUP 1)
Change in functional status and symptoms via EQ-5D-5L (Combined Outcome measurement)
EQ-5D-5L VAS is a standardised measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal visual analogue scale
Time frame: From baseline (day 1) up to day 98 (FUP 1)
cumulative number of: days alive out of hospital (Combined Outcome measurement)
Counted in days
Time frame: From baseline (day 1) up to day 180 (FUP 2)
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cumulative number of: non-fatal HF events (Combined Outcome measurement)
Counted in events
Time frame: From baseline (day 1) up to day 180 (FUP 2)
cumulative number of: hospital admissions (Combined Outcome measurement)
counted in numbers
Time frame: From baseline (day 1) up to day 180 (FUP 2)
death
Number of participants died within the defined time points
Time frame: From baseline (day 1) to day 180 (FUP 2)
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03 counted in numbers
Time frame: From baseline (day 1) to day 180 (FUP 2)