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Levosimendan In Ambulatory Heart Failure Patients (LEIA-HF)

Primary Purpose

Heart Failure New York Heart Association Class III, Heart Failure New York Heart Association Class IV, Heart Failure, Systolic

Status

Not yet recruiting

Phase

Phase 4

Locations

Poland

Study Type

Interventional

Intervention

Levosimendan

Placebo

About this trial

This is an interventional treatment trial for Heart Failure New York Heart Association Class III

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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

Sites / Locations

Medical University of Bialystok Clinical Hospital
Medical University Hospital No.1
Medical University Hospital No.2
Uniwersyteckie Centrum Kliniczne
Górnośląskie Centrum Medyczne Śląskiego Uniwersytetu Medycznego
Szpital Uniwersytecki w Krakowie
John Paul II Hospital
Medical University Hospital
University Hospital of Lord's Transfiguration
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Cardinal Stefan Wyszyński Institute of Cardiology
Uniwersytecki Szpital Kliniczny
Śląskie Centrum Chorób Serca
Provincial Specialist Hospital named after Dr. Wł. Biegański

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Levosimendan

Placebo

Arm Description

administration of levosimendan

administration of placebo

Outcomes

Primary Outcome Measures

the number of unplanned hospitalization

unplanned hospitalization due to heart failure decompensation

the number of deaths

death for any cause

Secondary Outcome Measures

total mortality calculations

total mortality for any cause

cardiovascular mortality calculations

mortality due to cardiovascular reasons

the number of planned hospitalization

planned hospitalization due to heart failure decompensation

the number of implantations of mechanical circulatory support

implantation of mechanical circulatory support

the number of heart transplantations

heart transplantation

quality of life measurements

The Kansas City Cardiomyopathy Questionnaire quality of life questionnaire- an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.

the six-minute walk test

measures the distance an individual is able to walk over a total of six minutes

NTproBNP measurements

measurements of NTproBNP concentrations

estimated glomerular filtration rate measurements

measurements of estimated glomerular filtration rate

echocardiographic parameters

the change in echocardiographic parameters assessed in transthoracic echocardiographic examination (TTE)

patients who returned to levosimendan / placebo infusions

calculations of the percentage of patients who returned to levosimendan / placebo infusions

Full Information

NCT ID

NCT04705337

First Posted

January 4, 2021

Last Updated

January 10, 2021

Sponsor

Medical University of Bialystok

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04705337

Brief Title

Levosimendan In Ambulatory Heart Failure Patients

Acronym

LEIA-HF

Official Title

Levosimendan In Ambulatory Heart Failure Patients

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Not yet recruiting

Study Start Date

January 1, 2021 (Anticipated)

Primary Completion Date

June 30, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medical University of Bialystok

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Levosimendan

Arm Type

Experimental

Arm Description

administration of levosimendan

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

administration of placebo

Intervention Type

Drug

Intervention Name(s)

Levosimendan

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

the number of unplanned hospitalization

Description

unplanned hospitalization due to heart failure decompensation

Time Frame

12 months of follow-up period

Title

the number of deaths

Description

death for any cause

Time Frame

12 months of follow-up period

Secondary Outcome Measure Information:

Title

total mortality calculations

Description

total mortality for any cause

Time Frame

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

Title

cardiovascular mortality calculations

Description

mortality due to cardiovascular reasons

Time Frame

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

Title

the number of planned hospitalization

Description

planned hospitalization due to heart failure decompensation

Time Frame

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

Title

the number of implantations of mechanical circulatory support

Description

implantation of mechanical circulatory support

Time Frame

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

Title

the number of heart transplantations

Description

heart transplantation

Time Frame

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

Title

quality of life measurements

Description

Time Frame

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

Title

the six-minute walk test

Description

measures the distance an individual is able to walk over a total of six minutes

Time Frame

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

Title

NTproBNP measurements

Description

measurements of NTproBNP concentrations

Time Frame

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

Title

estimated glomerular filtration rate measurements

Description

measurements of estimated glomerular filtration rate

Time Frame

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

Title

echocardiographic parameters

Description

the change in echocardiographic parameters assessed in transthoracic echocardiographic examination (TTE)

Time Frame

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

Title

patients who returned to levosimendan / placebo infusions

Description

calculations of the percentage of patients who returned to levosimendan / placebo infusions

Time Frame

from the 12th to the 18th months of the study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Agnieszka Tycińska, Prof.

Phone

+48 85 831 8656

agnieszka.tycinska@umb.edu.pl

First Name & Middle Initial & Last Name or Official Title & Degree

Andrzej Malkowski, PhD

Phone

+48 85 686 5122

andrzej.malkowski@umb.edu.pl

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Agnieszka Tycińska, Prof. MD

Organizational Affiliation

Medical University of Bialystok

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Marek Gierlotka, Prof. MD

Organizational Affiliation

University of Opole

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jarosław Kasprzak, Prof. MD

Organizational Affiliation

Medical University of Łódź

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jacek Kubica, Prof. MD

Organizational Affiliation

Nicolaus Copernicus University in Toruń

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Grzegorz Grześk, Prof. MD

Organizational Affiliation

Nicolaus Copernicus University in Toruń

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jadwiga Nessler, Prof. MD

Organizational Affiliation

John Paul II Hospital, Krakow

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Janina Stępińska, Prof. MD

Organizational Affiliation

Cardinal Stefan Wyszyński Institute of Cardiology

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Ewa Straburzyńska-Migaj, Prof. MD

Organizational Affiliation

Poznan University of Medical Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical University of Bialystok Clinical Hospital

City

Bialystok

ZIP/Postal Code

15-276

Country

Poland

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Agnieszka Tycinska, Prof. MD

agnieszka.tycinska@umb.edu.pl

First Name & Middle Initial & Last Name & Degree

Agnieszka Tycinska, Prof. MD

Facility Name

Medical University Hospital No.1

City

Bydgoszcz

ZIP/Postal Code

85-094

Country

Poland

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jacek Kubica, Prof. MD

First Name & Middle Initial & Last Name & Degree

Jacek Kubica, Prof. MD

Facility Name

Medical University Hospital No.2

City

Bydgoszcz

ZIP/Postal Code

85-168

Country

Poland

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Grzegorz Grześk, Prof. MD

First Name & Middle Initial & Last Name & Degree

Grzegorz Grześk, Prof. MD

Facility Name

Uniwersyteckie Centrum Kliniczne

City

Gdańsk

ZIP/Postal Code

80-952

Country

Poland

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Miłosz Jaguszewski, Prof. MD

First Name & Middle Initial & Last Name & Degree

Miłosz Jaguszewski, Prof. MD

Facility Name

Górnośląskie Centrum Medyczne Śląskiego Uniwersytetu Medycznego

City

Katowice

ZIP/Postal Code

40-635

Country

Poland

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wojciech Wojakowski, Prof. MD

First Name & Middle Initial & Last Name & Degree

Wojciech Wojakowski, Prof. MD

Facility Name

Szpital Uniwersytecki w Krakowie

City

Kraków

ZIP/Postal Code

30-688

Country

Poland

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Barbara Zawiślak, PhD MD

First Name & Middle Initial & Last Name & Degree

Barbara Zawiślak, PhD MD

Facility Name

John Paul II Hospital

City

Kraków

ZIP/Postal Code

31-202

Country

Poland

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jadwiga Nessler, Prof. MD

First Name & Middle Initial & Last Name & Degree

Jadwiga Nessler, Prof. MD

Facility Name

Medical University Hospital

City

Opole

Country

Poland

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marek Gierlotka, Prof. MD

First Name & Middle Initial & Last Name & Degree

Marek Gierlotka, Prof. MD

Facility Name

University Hospital of Lord's Transfiguration

City

Poznań

ZIP/Postal Code

61-848

Country

Poland

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ewa Straburzyńska-Migaj, Prof. MD

First Name & Middle Initial & Last Name & Degree

Ewa Straburzyńska-Migaj, Prof. MD

Facility Name

Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego

City

Warszawa

ZIP/Postal Code

02-097

Country

Poland

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Renata Główczyńska, ScD PhD MD

First Name & Middle Initial & Last Name & Degree

Renata Główczyńska, ScD PhD MD

Facility Name

Cardinal Stefan Wyszyński Institute of Cardiology

City

Warszawa

ZIP/Postal Code

04-628

Country

Poland

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Janina Stępińska, Prof. MD

First Name & Middle Initial & Last Name & Degree

Janina Stępińska, Prof. MD

Facility Name

Uniwersytecki Szpital Kliniczny

City

Wrocław

ZIP/Postal Code

50-556

Country

Poland

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Robert Zymliński, ScD PhD MD

First Name & Middle Initial & Last Name & Degree

Robert Zymliński, ScD PhD MD

Facility Name

Śląskie Centrum Chorób Serca

City

Zabrze

ZIP/Postal Code

41-800

Country

Poland

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mariusz Gąsior, Prof. MD

First Name & Middle Initial & Last Name & Degree

Mariusz Gąsior, Prof. MD

Facility Name

Provincial Specialist Hospital named after Dr. Wł. Biegański

City

Łódź

ZIP/Postal Code

91-347

Country

Poland

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jarosław Kasprzak, Prof. MD

First Name & Middle Initial & Last Name & Degree

Jarosław Kasprzak, Prof. MD

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

According to the agreement with the funding institution (Medical Research Agency), the sponsor and research centers must obtain the consent of the funding institution to disclose the clinical trial data.

Learn more about this trial

Levosimendan In Ambulatory Heart Failure Patients

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