Levosimendan In Ambulatory Heart Failure Patients

NCT04705337 | Terminated Phase 4 DMC

• 1 other identifier: 2019/ABM/01/00017
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 14

Brief 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

Outcome Measures

Primary Outcomes (2)

• the number of unplanned hospitalization

  unplanned hospitalization due to heart failure decompensation

  12 months of follow-up period

• the number of deaths

  death for any cause

  12 months of follow-up period

Secondary Outcomes (11)

• total mortality calculations

  0-12, 12-18 and 0-18 months

• cardiovascular mortality calculations

  0-12, 12-18 and 0-18 months

• the number of planned hospitalization

  0-12, 12-18 and 0-18 months

• the number of implantations of mechanical circulatory support

  0-12, 12-18 and 0-18 months

• the number of heart transplantations

  0-12, 12-18 and 0-18 months

Study Arms (2)

Levosimendan

EXPERIMENTAL

administration of levosimendan

Drug: Levosimendan

Placebo

PLACEBO COMPARATOR

administration of placebo

Other: Placebo

Interventions

Levosimendan DRUG

administration of levosimendan as a continuous iv. infusion, every 4 weeks for 48 weeks (12 infusions in total)

Levosimendan

Placebo OTHER

administration of glucose as a continuous iv. infusion, every 4 weeks for 48 weeks (12 infusions in total)

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent obtained before any trial activities
• Male or female, age ≥ 18 years at the time of signing informed consent
• Left ventricle ejection fraction ≤ 35%
• Hospitalization due to worsening of HF within the last 3 months
• New York Heart Association functional class III or outpatient IV
• Individually optimized pharmacotherapy, based on the current European Society of Cardiology recommendations, stable for at least 1 month prior to randomization, according to the knowledge and experience of the qualifying clinician
• Distance covered in six-minute walk test \<350m OR NTproBNP concentration ≥ 1000 pg/mL
• In the opinion of the Investigator, the patient does not currently require hospitalization
• Patient protected with an implantable device capable of terminating life-threatening arrhythmias and conduction disturbances (ICD or cardiac resynchronisation therapy-D/P), if indicated and the patient consents to implantation.

You may not qualify if:

• Known or suspected hypersensitivity to trial products or related products,
• Restrictive or hypertrophic cardiomyopathy, uncorrected severe valvular disease, potentially reversible cause of HF
• Hypotension with symptoms of tissue hypoperfusion
• Uncontrolled hypertension
• Planned revascularization or other surgical treatment of HF within the next year
• Advanced chronic kidney disease
• Features of liver damage
• Severe chronic lung disease with features of respiratory distress or severe abnormal spirometry or home oxygen treatment
• Accompanying chronic diseases with poor prognosis
• Paroxysmal supraventricular tachycardia, paroxysmal ventricular tachycardia, torsade de pointes, advanced atrioventricular blocks within one month prior to screening
• Receipt of any investigational product within 30 days before screening visit
• Any disorder, which in the investigator's opinion may jeopardise subject's safety or compliance with the study protocol and procedures

Sponsors & Collaborators

• Medical University of Bialystok: lead
• Medical Research Agency, Poland: collaborator
• University of Opole: collaborator
• Medical University of Lodz: collaborator
• Poznan University of Medical Sciences: collaborator
• Nicolaus Copernicus University: collaborator
• National Institute of Cardiology, Warsaw, Poland: collaborator
• Azienda Ospedaliera dei Colli: collaborator
• John Paul II Hospital, Krakow: collaborator

Study Sites (14)

Medical University of Bialystok Clinical Hospital

Bialystok, 15-276, Poland

Location

Medical University Hospital No.1

Bydgoszcz, 85-094, Poland

Location

Medical University Hospital No.2

Bydgoszcz, 85-168, Poland

Location

Uniwersyteckie Centrum Kliniczne

Gdansk, 80-952, Poland

Location

Górnośląskie Centrum Medyczne Śląskiego Uniwersytetu Medycznego

Katowice, 40-635, Poland

Location

Szpital Uniwersytecki w Krakowie

Krakow, 30-688, Poland

Location

John Paul II Hospital

Krakow, 31-202, Poland

Location

Provincial Specialist Hospital named after Dr. Wł. Biegański

Lodz, 91-347, Poland

Location

Medical University Hospital

Opole, Poland

Location

University Hospital of Lord's Transfiguration

Poznan, 61-848, Poland

Location

Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego

Warsaw, 02-097, Poland

Location

Cardinal Stefan Wyszyński Institute of Cardiology

Warsaw, 04-628, Poland

Location

Uniwersytecki Szpital Kliniczny

Wroclaw, 50-556, Poland

Location

Śląskie Centrum Chorób Serca

Zabrze, 41-800, Poland

Location

MeSH Terms

Conditions

Heart Failure, Systolic

Interventions

Simendan

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Hydrazones; Hydrazines; Organic Chemicals; Pyridazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Agnieszka Tycińska, Prof. MD

  Medical University of Bialystok

  STUDY CHAIR

• Marek Gierlotka, Prof. MD

  University of Opole

  PRINCIPAL INVESTIGATOR

• Jarosław Kasprzak, Prof. MD

  Medical University of Łódź

  PRINCIPAL INVESTIGATOR

• Jacek Kubica, Prof. MD

  Nicolaus Copernicus University in Toruń

  PRINCIPAL INVESTIGATOR

• Grzegorz Grześk, Prof. MD

  Nicolaus Copernicus University in Toruń

  PRINCIPAL INVESTIGATOR

• Jadwiga Nessler, Prof. MD

  John Paul II Hospital, Krakow

  PRINCIPAL INVESTIGATOR

• Janina Stępińska, Prof. MD

  Cardinal Stefan Wyszyński Institute of Cardiology

  PRINCIPAL INVESTIGATOR

• Ewa Straburzyńska-Migaj, Prof. MD

  Poznan University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2021
• First Posted: January 12, 2021
• Study Start: December 15, 2021
• Primary Completion: February 29, 2024
• Study Completion: August 15, 2024
• Last Updated: May 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

PL (14)