Heart failure & cardiomyopathiesRandomised controlled trial
The possible impact of levosimendan infusions on clinical course of heart failure: the results of the LEIA-HF study
- multicentre, randomized, double-blind, placebo-controlled, Phase IV clinical trial
- nine centres around Poland
- prematurely terminated
Authors' conclusion
In a selected group of stable ambulatory advanced HF (left ventricular ejection fraction ≤35%, New York Heart Association Classes III and IV) patients, repetitive levosimendan 24 h infusion might be an additional therapeutic option but observed deaths may raise its safety issue.
Study context
- Population
- Patients with ambulatory stable advanced heart failure (HF) (left ventricular ejection fraction ≤35%, New York Heart Association Classes III and IV)out of 350 planned
- Participants
- 64 patients
- Comparison
- Intermittent levosimendan vs placebo
- levosimendan group (study group)n = 34
- placebo groupn = 30
- Primary endpoint
- Death from any cause or unplanned hospitalization for HF, whichever occurred first
- Follow-up
- 12-month follow-up period
Primary result
As reported in the abstract
P = 0.14
Further findings
N-terminal pro-B-type natriuretic peptide concentrations in the study group
- significant decrease
- 5084 pg/ml (306-23.203) vs 2027 pg/ml (872-2174), P = .02
Left ventricular ejection fraction in the study group
- improvement
- 20.9 ± 5.9% vs 29.27 ± 5.23%, P = .015
Study conduct
- The study was prematurely terminated due to excess of deaths in the active treatment group
Safety
| Outcome | levosimendan group (study group) | placebo group | P value |
|---|---|---|---|
| Deaths · significantly higher deaths with levosimendan | 100% | 0 events | P = 0.02 |
Original publication
The possible impact of levosimendan infusions on clinical course of heart failure: the results of the LEIA-HF study. ESC Heart Fail. Published 16 January 2026. doi:10.1093/eschf/xvag021
Summarised from the published abstract; every number is checked against it