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    Summary
    EudraCT Number:2020-005893-93
    Sponsor's Protocol Code Number:00909043
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-01-25
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2020-005893-93
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled study evaluating levosimendan re-infusions in patients with severe heart failure with reduced left ventricular ejection fraction.
    Randomizowane, podwójnie zaślepione, kontrolowane
    placebo badanie, oceniające skuteczność powtarzanych
    wlewów levosimendanu u chorych z ciężką niewydolnością
    serca z obniżoną frakcją wyrzutową lewej komory
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    LEvosimendan In Ambulatory Heart Failure Patients (LEIA-HF)
    Levosimendan u ambulatoryjnych chorych z ciężką
    skurczową niewydolnością serca (LEIA-HF)
    A.3.2Name or abbreviated title of the trial where available
    LEIA-HF
    LEIA-HF
    A.4.1Sponsor's protocol code number00909043
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniwersytet Medyczny w Białymstoku
    B.1.3.4CountryPoland
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMedical Research Agency
    B.4.2CountryPoland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniwersytet Medyczny w Białymstoku
    B.5.2Functional name of contact pointBiuro Transferu Technologii
    B.5.3 Address:
    B.5.3.1Street AddressJana Kilińskiego 1
    B.5.3.2Town/ cityBiałystok
    B.5.3.3Post code15-089
    B.5.3.4CountryPoland
    B.5.4Telephone number+48856865122
    B.5.5Fax number+48856865122
    B.5.6E-mailbtt@umb.edu.pl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Simdax
    D.2.1.1.2Name of the Marketing Authorisation holderOrion Corporation
    D.2.1.2Country which granted the Marketing AuthorisationPoland
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameSimdax
    D.3.4Pharmaceutical form Concentrate and solvent for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboConcentrate for concentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Ambulatory Heart Failure Patients
    Ambulatoryjni chorzy z ciężką skurczową niewydolnością serca
    E.1.1.1Medical condition in easily understood language
    Heart Failure
    Choroba serca
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10074631
    E.1.2Term Systolic heart failure
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the effectiveness of repeated infusions of levosimendan in outpatients with advanced systolic HF in the prevention of death and recurrent hospitalizations.
    Określenie skuteczności powtarzanych wlewów levosimendanu u ambulatoryjnych pacjentów z zaawansowaną skurczową niewydolność serca w prewencji zgonu i nawracających rehospitalizacji.
    E.2.2Secondary objectives of the trial
    Not applicable
    Nie dotyczy.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Echocardiographic substudy of the LEIA-HF trial
    Studium echokardiograficzne badania LEIA-HF
    E.3Principal inclusion criteria
    Age ≥ 18 years
    • Heart failure with left ventricular ejection fraction ≤ 35%
    • Hospitalization for worsening heart failure within the last 6
    months
    • NYHA functional class III or outpatient IV
    • Optimal Medical Therapy (OMT) according to
    ESC guidelines, established as stable for at least 1 month before randomization, according to the knowledge and experience of the qualifying clinician
    • Distance covered in the 6-minute walk 6MWT <350 m OR NTproBNP concentration ≥ 1000 pg / mL
    • According to 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 CRT-D / P), if indicated and the patient consents to implantation.
    • Wiek ≥ 18 lat
    • Niewydolność serca z frakcją wyrzutową lewej komory ≤ 35%
    • Hospitalizacja z powodu zaostrzenia niewydolności serca w ciągu
    ostatnich 6 miesięcy
    • Klasa czynnościowa III lub ambulatoryjna IV wg klasyfikacji NYHA 5. Indywidualnie zoptymalizowana farmakoterapia (ang. Optimal Medical Therapy, OMT), zgodna z zaleceniami ESC, ustalona jako stabilna przez przynajmniej 1 miesiąc przed randomizacją, wg wiedzy i doświadczenia kwalifikującego klinicysty
    • Dystans pokonany w teście 6-cio minutowego marszu 6MWT < 350 m LUB stężenie NTproBNP ≥ 1000 pg/mL
    • W ocenie Badacza pacjent aktualnie nie wymagający hospitalizacji 8. Pacjent zabezpieczony wszczepialnym urządzeniem z funkcją
    przerywania zagrażających życiu zaburzeń rytmu i przewodzenia (ICD lub CRT-D/P), jeżeli istnieją wskazania i pacjent wyraża zgodę na implantację
    E.4Principal exclusion criteria
    • The etiology of heart failure that can be associated with restrictive cardiomyopathy or with hypertrophic cardiomyopathy or with uncorrected severe valvular disease according to the AHA / ACC / ESC criteria (Note: functional mitral valve insufficiency found on echocardiography does not exclude participation in the study) or heart failure with a probable reversible cause (tachyarrhythmic, alcohol, etc.)
    • Hypotension with symptoms of tissue hypoperfusion (systolic blood pressure <85 mmHg AND lactate concentration> 2 mmol / L - 'cold-wet' hemodynamic profile)
    • Uncontrolled hypertension
    • Planned revascularization or other surgical treatment of heart
    failure within the next 12 months (except for qualification or waiting for mechanical circulatory support or heart transplantation)
    • Advanced chronic kidney disease (eGFR <30 mL / min)
    • Biochemical features of liver injury (> 5 upper limit of the
    reference normal level of hepatic transaminases and / or> 3 upper limit of the reference limit of total bilirubin concentration)
    • Severe chronic lung disease with features of respiratory failure [defined as disorders of the respiratory system impairing gas exchange and leading to hypoxemia - arterial oxygen partial pressure (PaO2) <60mmHg (8.0 kPa) and / or hypercapnia - increase in partial pressure of carbon dioxide (PaCO2) ≥45mmHg (6.0 kPa)] or severe abnormalities in spirometry [defined as very severe obstruction, i.e. a decrease in forced expiratory volume in one second (FEV1 ) <35% predicted value] or home oxygen treatment [in chronic lung disease with features of respiratory failure, indications for home oxygen therapy include: PaO2 ≤55 mmHg (corresponding to saturation ≤88%); PaO2 55-60 mmHg (corresponding to saturation ≤88%) and pulmonary hypertension, peripheral edema suggesting right heart failure or polycythemia (hematocrit> 55%)].
    • Accompanying chronic diseases with poor prognosis (e.g. cancer)
    • Paroxysmal supraventricular tachycardia, paroxysmal ventricular tachycardia including torsade de pointes, advanced atrioventricular blocks in the month prior to study screening visit
    • History of hypersensitivity to levosimendan
    • Pregnancy or the postpartum period
    • A patient with predictable problems with cooperation with the medical and nursing team
    • Etiologia niewydolności serca możliwa do powiązania z kardiomiopatią restrykcyjną lub z kardiomiopatią przerostową lub z nieskorygowaną, ciężką chorobą zastawkową, zgodnie z kryteriami AHA/ACC/ESC (Uwaga: czynnościowa niedomykalność zastawki mitralnej stwierdzana w badaniu echokardiograficznym nie powoduje wykluczenia z udziału w badaniu) lub niewydolność serca o prawdopodobnej przyczynie odwracalnej (tachyarytmiczna, alkoholowa, itp.)
    • Hipotonia z objawami hipoperfuzji tkankowej (skurczowe ciśnienie tętnicze < 80 mmHg
    • Niekontrolowane nadciśnienie tętnicze
    • Planowana rewaskularyzacja lub inne leczenie zabiegowe
    niewydolności serca w ciągu najbliższych 12 miesięcy (z wyjątkiem kwalifikacji lub oczekiwania na wszczepienie mechanicznego wspomagania krążenia lub transplantację serca)
    • Zaawansowana przewlekła choroba nerek (eGFR < 30 mL/min.)
    • Biochemiczne cechy uszkodzenia wątroby (> 5 górnej granicy normy referencyjnej aktywności aminotransferaz wątrobowych i/lub > 3 górnej granicy normy referencyjnej stężenia całkowitej bilirubiny)
    • Ciężka przewlekła choroba płuc z cechami niewydolności oddechowej [definiowanej jako zaburzenia czynności układu oddechowego upośledzające wymianę gazową i prowadzące do hipoksemii - ciśnienie parcjalne tlenu we krwi tętniczej (PaO2) < 60 mmHg (8,0 kPa) i/lub hiperkapnii - wzrost ciśnienia parcjalnego dwutlenku węgla (PaCO2) ≥ 45 mmHg (6,0 kPa)] i/lub SpO2 < 90% na powietrzu atmosferycznym lub ciężkimi nieprawidłowościami w spirometrii [definiowanymi jako bardzo ciężka obturacja, czyli spadek natężonej objętości wydechowej pierwszosekundowej (FEV1) < 35% wartości należnej] lub domowe leczenie tlenem [w przewlekłej chorobie płuc z cechami niewydolności oddechowej do wskazań do domowej terapii tlenem należą: PaO2 ≤ 55 mmHg (odpowiada to saturacji ≤ 88%); PaO2 55-60 mmHg (odpowiada to saturacji ≤ 88%) oraz nadciśnienie płucne, obrzęki obwodowe sugerujące prawokomorową niewydolność serca lub policytemia (hematokryt > 55%)].
    • Towarzyszące choroby przewlekłe o złym rokowaniu (np. choroba nowotworowa)
    • Napadowy częstoskurcz nadkomorowy, napadowy częstoskurcz komorowy, w tym torsade de pointes, zaawansowane bloki przedsionkowo-komorowe w ciągu miesiąca przed wizytą kwalifikującą do badania
    • Nadwrażliwość na levosimendan w wywiadzie
    • Ciąża lub okres połogu
    • Pacjent o przewidywalnych problemach ze współpracą z zespołem lekarsko-pielęgniarskim
    • Aktualna infekcja wirusem SARS-Cov2 lub dodatni wynik PCR w kierunku infekcji SARS-Cov-2 w ciągu ostatniego miesiąca.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint: death OR unplanned hospitalization due to heart failure (according to ICD-10: I50, R57.0), assessed jointly, depending on what occurs earlier in the 12-month follow-up.
    Pierwszorzędowym punktem końcowym dla oceny skuteczności: • zgon z dowolnej przyczyny LUB nieplanowana hospitalizacja z powodu niewydolności serca (wg ICD-10: I50, R57.0), oceniane łącznie, w zależności od tego, co wystąpi wcześniej w obserwacji 12 miesięcznej.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    12 miesięcy
    E.5.2Secondary end point(s)
    • Death from any cause;
    • Death from cardiovascular causes (according to ICD-10: the
    whole group I00-I99);
    • Unplanned hospitalization for heart failure;
    • All-cause death OR unscheduled hospitalization for heart
    failure at the 12-18 month and 0-18 month time points;
    • Death from cardiovascular causes OR unplanned
    hospitalization for heart failure;
    • Implantation of a mechanical circulatory support system
    (according to ICD-9-CM: 37.62, 37.66);
    • Heart transplantation or implantation of a system that
    completely replaces the heart function (according to ICD-9-
    CM: 37.51, 37.52, 33.6);
    • Implantation of a mechanical circulatory support system or
    heart transplant or implantation of a system that completely
    replaces the work of the heart;
    • Time to the first unscheduled hospitalization for heart failure
    in the subgroup of unplanned hospitalization for heart failure;
    • Time to implantation of a mechanical circulatory support system, heart transplantation or implantation of a system that completely replaces the work of the heart;
    • Percentage of patients who returned to levosimendan / placebo infusions in the 13th to 18th month phase of the study;
    • Quality of life (QoL) assessed using the KCCQ questionnaire;
    • Distance in meters covered in the 6-minute walk 6MWT test;
    • NTproBNP concentration;
    • eGFR according to CDK-EPI;
    • Selected echocardiographic parameters.
    • Zgon z dowolnej przyczyny;
    • Zgon z przyczyn sercowo-naczyniowych (wg ICD-10: cała grupa
    I00- I99);
    • Nieplanowana hospitalizacja z powodu niewydolności serca;
    • Zgon z dowolnej przyczyny LUB nieplanowana hospitalizacja z
    powodu niewydolności serca w punktach czasowych 12-18
    miesięcy i 0-18 miesięcy;
    • Zgon z przyczyn sercowo-naczyniowych LUB nieplanowana
    hospitalizacja z powodu niewydolności serca;
    • Implantacja systemu do mechanicznego wspomagania krążenia
    (wg ICD-9-CM: 37.62, 37.66);
    • Transplantacja serca lub wszczepienie systemu całkowicie
    zastępującego pracę serca (wg ICD-9-CM: 37.51, 37.52, 33.6);
    • Implantacja systemu do mechanicznego wspomagania krążenia
    lub transplantacja serca lub wszczepienie systemu całkowicie
    zastępującego pracę serca;
    • Czas do pierwszej nieplanowanej hospitalizacji z powodu
    niewydolności serca w podgrupie pacjentów nieplanowo hospitalizowanych z powodu niewydolności serca;
    • Czas do implantacji systemu do mechanicznego wspomagania
    krążenia, transplantacji serca lub wszczepienia systemu
    całkowicie zastępującego pracę serca;
    • Odsetek pacjentów, u których powrócono do wlewów
    levosimendanu/placebo w fazie od 13-go do 18-go miesiąca
    badania;
    • Jakość życia (QoL) oceniana za pomocą kwestionariusza KCCQ;
    • Dystans w metrach pokonany w teście 6-cio minutowego marszu
    6MWT;
    • Stężenie NTproBNP;
    • eGFR wg CDK-EPI;
    • Wybrane parametry echokardiograficzne.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Assessed in the following windows: 0-12 months, 12-18 months oraz 0-18 months
    Oceniane w oknach czasowych: 0-12 miesięcy, 12-18 miesięcy oraz 0-18 miesięcy
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned15
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 350
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 350
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state350
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Nie dotyczy
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-09-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-28
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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