A Phase 4 interventional study of Levosimendan and Placebo in Heart Failure, sponsored by Finn Gustafsson. Status unknown at 3 sites in Denmark. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2019-07-17.
Sponsored by Finn Gustafsson · Phase 4, Interventional, and Treatment
Purpose: This study evaluates the subacute effect of levosimendan infusion on exercise capacity and exercise hemodynamics compared with placebo in patients with advanced chronic heart failure.
Hypothesis: Treatment with 6 hours infusion of levosimendan compared with placebo improves exercise capacity and exercise hemodynamics evaluated by change in CO/PCWP.
Design: The study is a prospective multi-center, double-blinded, placebo controlled randomized study. 42 consecutive patients who meet the eligibility criteria will be enrolled.
Background: Patients with advanced heart failure (HF) symptoms (NYHA III-IV) have poor quality of life and significantly impaired functional capacity despite optimal medical management. Exercise intolerance in HF results from multiple pathophysiological processes, but central hemodynamics during exercise are important determinants. In patients with advanced HF, intermittent levosimendan infusion is sometimes used to relieve symptoms and possibly improve prognosis. A short-term effect of levosimendan infusion on exercise capacity has previously been reported. However, the underlying mechanisms behind such an improvement, as well as more durable effects of levosimendan on exercise capacity in advanced chronic HF, have not been clearly established. Also the hemodynamic effect of levosimendan has not been investigated in advanced chronic HF during exercise.
To our knowledge no previous studies have evaluated the subacute effect of levosimendan infusion on exercise capacity and exercise hemodynamics in patients with advanced chronic HF. This study will hopefully improve the understanding of the role of levosimendan in the management of these patients.
Purpose: This study evaluates the subacute effect of levosimendan infusion on exercise capacity and exercise hemodynamics compared with placebo in patients with advanced chronic HF.
Hypothesis: Treatment with 6 hours infusion of levosimendan 0.2 µg/kg/min compared with placebo improves exercise capacity and exercise hemodynamics evaluated by change in CO/PCWP (Day 0 to Day 5 (4-6) after infusion) in patients with advanced chronic HF.
Design: The study is a prospective multi-center, double-blinded, placebo controlled randomized study. The study population will consist of 42 consecutive patients who meet the eligibility criteria. Patients will be randomized 1:1 to treatment with either levosimendan or placebo.
5,803 studies on the registry are indexed under Heart Failure; 1,222 are open to participants now.
This study's planned enrollment of 42 is below the median of 72 across 3,790 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Finn Gustafsson is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
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Study participants in this arm will receive a 6 hours infusion of levosimendan 0.2 µg/kg/min.
Drug: Levosimendan
Study participants in this arm will receive a 6 hours infusion of placebo (sterile isotonic sodium chloride + 5% dextrose + vitamin B)
Drug: Placebo
Levosimendan, 2.5 mg/mL concentrate for dilution. 5 mL of the study drug will be injected into a 245 mL isotonic glucose solution. Patients will receive a 6 hours infusion of this study drug at an infusion rate of 0.2 µg/kg/min.
Also known as: Simdax
The placebo solution will be prepared by adding 10 mL of 5% dextrose to a vial containing Soluvit (vitamin B) under aseptical conditions. 5 mL of this solution is then added to 245 mL of isotonic sodium chloride solution. 5% dextrose and vitamin B are added to ensure yellow coloring indistinguishable from the active drug (levosimendan). Patients will receive a 6 hours infusion of this study drug. Infusion rate will be calculated in similar fashion to the levosimendan group.
ΔCO/PCWP (submax)
Change in CO/PCWP from Day 0 (infusion of study medication) to Day 5 (day 4-6) at the workload corresponding to 50% of pVO2 determined at baseline
Time frame: Day 0 to Day 5 (4-6)
ΔCO/PCWP (peak)
Change in CO/PCWP from Day 0 (infusion of study medication) to Day 5 (day 4-6) at peak exercise
Time frame: Day 0 to Day 5 (4-6)
ΔCO (peak)
Change in maximal CO from Day 0 (infusion of study medication) to Day 5 (day 4-6) at peak exercise
Time frame: Day 0 to Day 5 (4-6)
ΔPCWP (peak)
Change in PCWP from Day 0 (infusion of study medication) to Day 5 (day 4-6) at the maximal load obtained during both invasive measurements
Time frame: Day 0 to Day 5 (4-6)
CO maximal
Maximal CO at Day 5 (day 4-6)
Time frame: Day 5
PCWP maximal
Maximal PCWP at Day 5 (day 4-6)
Time frame: Day 5
SvO2 maximal
Maximal SvO2 at Day 5 (day 4-6)
Time frame: Day 5
Workload maximal
Maximal workload (watt) at Day 5 (day 4-6)
Time frame: Day 5
ΔPCWP (rest)
Change in resting PCWP from Day 0 (infusion of study medication) to Day 5 (day 4-6)
Time frame: Day 0 to Day 5 (4-6)
ΔCO (rest)
Change in resting CO from Day 0 (infusion of study medication) to Day 5 (day 4-6)
Time frame: Day 0 to Day 5 (4-6)
ΔCVP (rest)
Change in resting CVP from Day 0 (infusion of study medication) to Day 5 (day 4-6)
Time frame: Day 0 to Day 5 (4-6)
ΔmPA (rest)
Change in resting mPA from Day 0 (infusion of study medication) to Day 5 (day 4-6)
Time frame: Day 0 to Day 5 (4-6)
ΔSvO2 (rest)
Change in resting SvO2 from Day 0 (infusion of study medication) to Day 5 (day 4-6)
Time frame: Day 0 to Day 5 (4-6)
Δ6MWT day 3
Change in 6MWT from Day 0 (infusion of study medication) to Day 3
Time frame: Day 0 to Day 3
Δ6MWT day 5 (4-6)
Change in 6MWT from Day 0 (infusion of study medication) to Day 5 (day 4-6)
Time frame: Day 0 to Day 5 (day 4-6)
Δ6MWT day 14
Change in 6MWT from Day 0 (infusion of study medication) to Day 14
Time frame: Day 0 to Day 14
ΔNT-proBNP day 3
Change in NT-proBNP from Day 0 (infusion of study medication) to Day 3
Time frame: Day 0 to Day 3
ΔNT-proBNP day 5
Change in NT-proBNP from Day 0 (infusion of study medication) to Day 5 (day 4-6)
Time frame: Day 0 to Day 5 (day 4-6)
ΔNT-proBNP day 14
Change in NT-proBNP from Day 0 (infusion of study medication) to Day 14
Time frame: Day 0 to Day 14
QOL day 3
Quality of life (QOL) score using the Kansas City Cardiomyopathy Questionnaire (KCCQ) at Day 3 after infusion of study medication
Time frame: Day 3
QOL day 5
Quality of life (QOL) score using the Kansas City Cardiomyopathy Questionnaire (KCCQ) at Day 5 (4-6) after infusion of study medication
Time frame: Day 5
QOL Day 14
Quality of life (QOL) score using the Kansas City Cardiomyopathy Questionnaire (KCCQ) at Day 14 after infusion of study medication
Time frame: Day 14
This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Simendan
Finn Gustafsson