Levosimendan In Ambulatory Heart Failure Patients

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).

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

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)

Sponsors & Collaborators

• Medical Research Agency, Poland

  collaborator OTHER_GOV

• University of Opole

  collaborator OTHER

• Medical University of Lodz

  collaborator OTHER

• Poznan University of Medical Sciences

  collaborator OTHER

• Nicolaus Copernicus University

  collaborator OTHER

• National Institute of Cardiology, Warsaw, Poland

  collaborator OTHER

• Azienda Ospedaliera dei Colli

  collaborator OTHER

• John Paul II Hospital, Krakow

  collaborator OTHER

• Medical University of Bialystok

  lead OTHER

Principal Investigators

• Agnieszka Tycińska, Prof. MD · Medical University of Bialystok

• Marek Gierlotka, Prof. MD · University of Opole

• Jarosław Kasprzak, Prof. MD · Medical University of Łódź

• Jacek Kubica, Prof. MD · Nicolaus Copernicus University in Toruń

• Grzegorz Grześk, Prof. MD · Nicolaus Copernicus University in Toruń

• Jadwiga Nessler, Prof. MD · John Paul II Hospital, Krakow

• Janina Stępińska, Prof. MD · Cardinal Stefan Wyszyński Institute of Cardiology

• Ewa Straburzyńska-Migaj, Prof. MD · Poznan University of Medical Sciences

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-12-15

Primary Completion

2024-02-29

Completion

2024-08-15

Countries

• Poland

Study Locations