Heart Failure New York Heart Association Class IIIPhase 4LEIA-HFNCT04705337
Levosimendan In Ambulatory Heart Failure Patients
A Phase 4 study testing Levosimendan in people with Heart Failure New York Heart Association Class III and Heart Failure New York Heart Association Class IV, run by Medical University of Bialystok at 14 sites in Poland.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure New York Heart Association Class III, Heart Failure New York Heart Association Class IV, Heart Failure, Systolic
- What is being tested?
- Levosimendan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 14 sitesPoland
- Study dates
- 15 Dec 2021to 15 Aug 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Poland14 sites
Medical University of Bialystok Clinical Hospital
Bialystok, 15-276
Medical University Hospital No.1
Bydgoszcz, 85-094
Medical University Hospital No.2
Bydgoszcz, 85-168
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-952
Górnośląskie Centrum Medyczne Śląskiego Uniwersytetu Medycznego
Katowice, 40-635
Szpital Uniwersytecki w Krakowie
Krakow, 30-688
John Paul II Hospital
Krakow, 31-202
Provincial Specialist Hospital named after Dr. Wł. Biegański
Lodz, 91-347
Medical University Hospital
Opole
University Hospital of Lord's Transfiguration
Poznan, 61-848
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Warsaw, 02-097
Cardinal Stefan Wyszyński Institute of Cardiology
Warsaw, 04-628
Uniwersytecki Szpital Kliniczny
Wroclaw, 50-556
Śląskie Centrum Chorób Serca
Zabrze, 41-800
About this study
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).
Read the 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
- Being tested
- Levosimendan, Placebo
- Medical subject headings
- Heart Failure, Systolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevosimendanDrug
administration of levosimendan as a continuous iv. infusion, every 4 weeks for 48 weeks (12 infusions in total)
PlaceboOther
administration of glucose as a continuous iv. infusion, every 4 weeks for 48 weeks (12 infusions in total)
| Study group | Role | What they receive |
|---|---|---|
| Levosimendan | Experimental | administration of levosimendan Receives: Drug: Levosimendan |
| Placebo | Placebo comparator | administration of placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of unplanned hospitalization
unplanned hospitalization due to heart failure decompensation
Measured: 12 months of follow-up period
the number of deaths
death for any cause
Measured: 12 months of follow-up period
Secondary outcomes (11)
total mortality calculations
total mortality for any cause
Measured: 0-12, 12-18 and 0-18 months
cardiovascular mortality calculations
mortality due to cardiovascular reasons
Measured: 0-12, 12-18 and 0-18 months
the number of planned hospitalization
planned hospitalization due to heart failure decompensation
Measured: 0-12, 12-18 and 0-18 months
the number of implantations of mechanical circulatory support
implantation of mechanical circulatory support
Measured: 0-12, 12-18 and 0-18 months
the number of heart transplantations
heart transplantation
Measured: 0-12, 12-18 and 0-18 months
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.
Measured: 0-12, 12-18 and 0-18 months
the six-minute walk test
measures the distance an individual is able to walk over a total of six minutes
Measured: 0-12, 12-18 and 0-18 months
NTproBNP measurements
measurements of NTproBNP concentrations
Measured: 0-12, 12-18 and 0-18 months
estimated glomerular filtration rate measurements
measurements of estimated glomerular filtration rate
Measured: 0-12, 12-18 and 0-18 months
echocardiographic parameters
the change in numerous echocardiographic parameters with different units assessed in each patient in transthoracic echocardiographic examination (TTE)
Measured: 0-12, 12-18 and 0-18 months
patients who returned to levosimendan / placebo infusions
calculations of the percentage of patients who returned to levosimendan / placebo infusions
Measured: from the 12th to the 18th months of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start15 Dec 2021
- Primary completion29 Feb 2024
- Study completion15 Aug 2024
Why it stopped: The level of recruitment, 62 participants enrolled, does not allow for achieving the protocol-defined target of 350 participants by the end of the recruitment period.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure New York Heart Association Class IIIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Bialystok
- Sponsor type
- University, hospital or other
- 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, Azienda Ospedaliera dei Colli, John Paul II Hospital, Krakow
- Responsible party
- Sponsor
- Investigators
- Agnieszka Tycińska, Prof. MD, Study chair, Medical University of BialystokMarek Gierlotka, Prof. MD, Principal investigator, University of OpoleJarosław Kasprzak, Prof. MD, Principal investigator, Medical University of ŁódźJacek Kubica, Prof. MD, Principal investigator, Nicolaus Copernicus University in ToruńGrzegorz Grześk, Prof. MD, Principal investigator, Nicolaus Copernicus University in ToruńJadwiga Nessler, Prof. MD, Principal investigator, John Paul II Hospital, KrakowJanina Stępińska, Prof. MD, Principal investigator, Cardinal Stefan Wyszyński Institute of CardiologyEwa Straburzyńska-Migaj, Prof. MD, Principal investigator, Poznan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04705337
- Sponsor's protocol ID
- 2019/ABM/01/00017
- Acronym
- LEIA-HF
- Status last verified
- May 2025
- First submitted
- 4 Jan 2021
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Levosimendan In Ambulatory Heart Failure Patients
- ClinicalTrials.gov ID
- NCT04705337
- Acronym / sponsor ID
- LEIA-HF / 2019/ABM/01/00017
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The level of recruitment, 62 participants enrolled, does not allow for achieving the protocol-defined target of 350 participants by the end of the recruitment period.
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Medical University of BialystokUniversity, hospital or other
- 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, Azienda Ospedaliera dei Colli, John Paul II Hospital, Krakow
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 12 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levosimendan | Experimental | Drug: Levosimendanadministration of levosimendan |
| Placebo | Placebo comparator | Other: Placeboadministration of placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levosimendanadministration of levosimendan as a continuous iv. infusion, every 4 weeks for 48 weeks (12 infusions in total) | Drug | Levosimendan |
| Placeboadministration of glucose as a continuous iv. infusion, every 4 weeks for 48 weeks (12 infusions in total) | Other | Placebo |
Primary outcome
the number of unplanned hospitalization
Time frame: 12 months of follow-up period
unplanned hospitalization due to heart failure decompensation
the number of deaths
Time frame: 12 months of follow-up period
death for any cause
11 secondary outcomes
total mortality calculations
Time frame: 0-12, 12-18 and 0-18 months
cardiovascular mortality calculations
Time frame: 0-12, 12-18 and 0-18 months
the number of planned hospitalization
Time frame: 0-12, 12-18 and 0-18 months
the number of implantations of mechanical circulatory support
Time frame: 0-12, 12-18 and 0-18 months
the number of heart transplantations
Time frame: 0-12, 12-18 and 0-18 months
quality of life measurements
Time frame: 0-12, 12-18 and 0-18 months
the six-minute walk test
Time frame: 0-12, 12-18 and 0-18 months
NTproBNP measurements
Time frame: 0-12, 12-18 and 0-18 months
estimated glomerular filtration rate measurements
Time frame: 0-12, 12-18 and 0-18 months
echocardiographic parameters
Time frame: 0-12, 12-18 and 0-18 months
patients who returned to levosimendan / placebo infusions
Time frame: from the 12th to the 18th months of the study
Results and safety
The study was stopped early (reason given: The level of recruitment, 62 participants enrolled, does not allow for achieving the protocol-defined target of 350 participants by the end of the recruitment period.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
- Individual participant dataSharing planned: No. 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.
Related trials for Heart Failure New York Heart Association Class III
Recruiting
Barostim-Enabled NEurohormonal Intervention For Improving Treatment of Heart Failure
Heart Failure, Heart Failure NYHA Class II
Recruiting
PrEcision Pacing in HFpEF: the PEP-HFpEF Trial
Heart Failure and Preserved Ejection Fraction, Heart Failure New York Heart Association Class III
Active, not recruiting
Neural Cardiac Therapy for Heart Failure Study (NECTAR-HF)
Heart Failure, Congestive Heart Failure
Recruiting
NORM-HF Pivotal Study
Heart Failure, NYHA Class III Heart Failure
Not yet recruiting
Inspiratory Muscle Training in Hospitalized Patients With Heart Failure Awaiting Advanced Therapies
Heart Failure, Heart Failure New York Heart Association Class III
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Agnieszka Tycińska, Prof. MD study chair
Medical University of Bialystok
Marek Gierlotka, Prof. MD principal investigator
University of Opole
Jarosław Kasprzak, Prof. MD principal investigator
Medical University of Łódź
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levosimendan in people with Heart Failure New York Heart Association Class III and Heart Failure New York Heart Association Class IV, run by Medical University of Bialystok at 14 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The level of recruitment, 62 participants enrolled, does not allow for achieving the protocol-defined target of 350 participants by the end of the recruitment period.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the number of unplanned hospitalization (time frame: 12 months of follow-up period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.