Levosimendan In Ambulatory Heart Failure Patients — LEIA-HF  

Heart Failure With Reduced Ejection Fraction Clinical Trial

Official title: Levosimendan In Ambulatory Heart Failure Patients

Status Not yet recruiting

Clinical Trial Summary

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).

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure New York Heart Association Class III
• Heart Failure New York Heart Association Class IV
• Heart Failure With Reduced Ejection Fraction
• Heart Failure, Systolic

• NCT number: NCT04705337
• Study type: Interventional
• Source: Medical University of Bialystok
• Contact: Agnieszka Tycinska, Prof.
• Phone: +48 85 831 8656
• Email: agnieszka.tycinska@umb.edu.pl
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: January 1, 2021
• Completion date: December 31, 2024