NCT04705337

Levosimendan In Ambulatory Heart Failure Patients

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Medical University of Bialystok · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Levosimendan	administration of levosimendan as a continuous iv. infusion, every 4 weeks for 48 weeks (12 infusions in total)
OTHER	Placebo	administration of glucose as a continuous iv. infusion, every 4 weeks for 48 weeks (12 infusions in total)

Timeline

• Start date: 2021-12-15
• Primary completion: 2024-02-29
• Completion: 2024-08-15
• First posted: 2021-01-12
• Last updated: 2025-05-09

Locations

14 sites across 1 country: Poland