Oral levosimendan did not improve the Patient Journey composite score compared to placebo in patients with severe chronic heart failure (p=0.567), despite improvements in quality of life and NT-proBNP.
RCT (n=307)
double-blind
randomly assigned
p-value: p=0.567
BACKGROUND: Intravenous levosimendan improves symptoms in acutely decompensated heart failure. AIMS: To evaluate the effects of oral levosimendan in severe chronic heart failure (CHF). METHODS: 307 patients with NYHA IIIB-IV CHF were randomly assigned, double-blind, to levosimendan 1 mg once or twice daily or placebo for at least 180 days. An exploratory primary end-point, the Patient Journey, a composite consisting of repeated symptom assessments, worsening heart failure and mortality during 60 days was used. Minnesota Living with Heart Failure quality of life score (MLHFQoL) and NT-proBNP were assessed repeatedly. RESULTS: Patients assigned to a lower dose of levosimendan had more severe CHF at baseline. No differences in symptoms emerged and worsening heart failure events and death were similar resulting in a similar Patient Journey score with levosimendan and placebo (p=0.567). Compared to placebo, a net improvement of 3-4 points in MLHFQoL at several time-points in favour of the combined levosimendan groups was observed (p<0.001) which was accompanied by a substantial and persistent reduction in NT-proBNP (-30-40%) (p<0.001). CONCLUSION: Levosimendan improved QoL and decreased NT-proBNP but did not improve the Patient Journey composite in patients with severe CHF. Further research with this compound is warranted to clarify safety and efficacy.
Nieminen et al. (Wed,) conducted a rct in severe chronic heart failure (CHF) (n=307). oral levosimendan vs. placebo was evaluated on Patient Journey, a composite consisting of repeated symptom assessments, worsening heart failure and mortality during 60 days (p=0.567). Oral levosimendan did not improve the Patient Journey composite score compared to placebo in patients with severe chronic heart failure (p=0.567), despite improvements in quality of life and NT-proBNP.