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    Summary
    EudraCT Number:2020-005302-26
    Sponsor's Protocol Code Number:DW.0701.005.2020P
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-06-30
    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 number2020-005302-26
    A.3Full title of the trial
    The effect of sacubitril/valsartan versus ramipril on left ventricular function and remodeling in patients with ischemic heart failure with mid-range ejection fraction
    Wpływ sakubitrylu/walsartanu w porównaniu z ramiprylem na przebudowę i funkcję lewej komory u pacjentów z niewydolnością serca o etiologii niedokrwiennej i pośredniej frakcji wyrzutowej
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of sacubitril/valsartan versus ramipril on left ventricular function and remodeling in patients with ischemic heart failure with mid-range ejection fraction
    Wpływ sakubitrylu/walsartanu w porównaniu z ramiprylem na przebudowę i funkcję lewej komory u pacjentów z niewydolnością serca o etiologii niedokrwiennej i pośredniej frakcji wyrzutowej
    A.3.2Name or abbreviated title of the trial where available
    CRACOVIA-HF
    A.4.1Sponsor's protocol code numberDW.0701.005.2020P
    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 SponsorJohn Paul II Hospital
    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 organisationJadwiga Nessler
    B.5.2Functional name of contact pointStudy Coordinator
    B.5.3 Address:
    B.5.3.1Street AddressPrądnicka 80
    B.5.3.2Town/ cityCracow
    B.5.3.3Post code31-202
    B.5.3.4CountryPoland
    B.5.4Telephone number+48126142582
    B.5.6E-mailbadaniakliniczne@szpitaljp2.krakow.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 Entresto 49 mg/51 mg film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSacubitril
    D.3.9.1CAS number 149709-62-6
    D.3.9.3Other descriptive nameDB09292 – Drug Bank
    D.3.9.4EV Substance CodeSUB170848
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number48.6
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNValsartan
    D.3.9.1CAS number 137862-53-4
    D.3.9.3Other descriptive nameDB00177 – Drug Bank
    D.3.9.4EV Substance CodeSUB00017MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number51.4
    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.IMP: 2
    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 Entresto 97 mg/103 mg film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSacubitril
    D.3.9.1CAS number 149709-62-6
    D.3.9.3Other descriptive nameDB09292 – Drug Bank
    D.3.9.4EV Substance CodeSUB170848
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number97.2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNValsartan
    D.3.9.1CAS number 137862-53-4
    D.3.9.3Other descriptive nameDB00177 – Drug Bank
    D.3.9.4EV Substance CodeSUB00017MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number102.8
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Axtil 2,5 mg
    D.2.1.1.2Name of the Marketing Authorisation holderAdamed Pharma S.A.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRamipril
    D.3.9.1CAS number 87333-19-5
    D.3.9.3Other descriptive nameDB00178 - DrugBank
    D.3.9.4EV Substance CodeSUB10248MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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.IMP: 4
    D.1.2 and D.1.3IMP RoleComparator
    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 Axtil 5 mg
    D.2.1.1.2Name of the Marketing Authorisation holderAdamed Pharma S.A.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRamipril
    D.3.9.1CAS number 87333-19-5
    D.3.9.3Other descriptive nameDB00178 - DrugBank
    D.3.9.4EV Substance CodeSUB10248MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 4
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    heart failure with moderately reduced ejection fraction (HFmrEF)
    niewydolność serca z pośrednią frakcją wyrzutową
    E.1.1.1Medical condition in easily understood language
    chronic heart failure
    przewlekła niewydolność 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 10010684
    E.1.2Term Congestive 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
    The purpose of the study is to evaluate the effect of sacubitril / valsartan versus ramipril on left ventricular remodeling and function in ischemic HFmrEF patients.
    The primary objective of the study is to evaluate the effect of sacubitril / valsartan versus ramipril on the change in left ventricular end-systolic volume as measured by magnetic resonance imaging (MRI) in patients with ischemic HFmrEF after 12 months of treatment.
    Celem badania jest ocena wpływu sakubitrylu/walsartanu w porównaniu z ramiprylem na przebudowę i funkcję lewej komory u pacjentów z HFmrEF o etiologii niedokrwiennej.
    Pierwszorzędowym celem badania jest ocena wpływu sakubitrylu/walsartanu w porównaniu z ramiprylem na zmianę objętości końcowo-skurczowej lewej komory zmierzonej metodą rezonansu magnetycznego (MRI) u pacjentów z HFmrEF o etiologii niedokrwiennej po 12 miesiącach leczenia.
    E.2.2Secondary objectives of the trial
    Assessment of the effect of sacubitril / valsartan compared to ramipril on
    1. change in left ventricular end-diastolic volume measured by MRI
    2. change in indexed left ventricular end-systolic and end-diastolic volumes measured by MRI
    3. change in left ventricular ejection fraction measured by MRI
    4. occurrence of the endpoint of death from cardiovascular causes or first hospitalization for HF
    5. the occurrence of the endpoint of death from cardiovascular causes or first or subsequent hospitalization for HF
    6. occurrence of death from cardiovascular causes
    7. first hospitalization due to HF
    8. occurrence of the first or subsequent hospitalization due to HF
    9. time to death from cardiovascular causes or first hospitalization for HF
    10. occurrence of death from any cause
    in patients with ischemic HFmrEF over a 12 month treatment period.
    Ocena wpływu sakubitrylu/walsartanu w porównaniu z ramiprylem na
    1. zmianę objętości końcowo-rozkurczowej lewej komory zmierzonej metodą MRI
    2. zmianę zindeksowanych wartości objętości końcowo-skurczowej i końcowo-rozkurczowej lewej komory zmierzonych metodą MRI
    3. zmianę frakcji wyrzutowej lewej komory zmierzonej metodą MRI
    4. wystąpienie punktu końcowego złożonego ze zgonu z przyczyn sercowo-naczyniowych lub pierwszej hospitalizacji z powodu HF
    5. wystąpienie punktu końcowego złożonego ze zgonu z przyczyn sercowo-naczyniowych lub pierwszej lub kolejnej hospitalizacji z powodu HF
    6. wystąpienie zgonu z przyczyn sercowo-naczyniowych
    7. wystąpienie pierwszej hospitalizacji z powodu HF
    8. wystąpienie pierwszej lub kolejnej hospitalizacji z powodu HF
    9. czas do wystąpienia zgonu z przyczyn sercowo-naczyniowych lub pierwszej hospitalizacji z powodu HF
    10. wystąpienie zgonu z jakiejkolwiek przyczyny
    u pacjentów z HFmrEF o etiologii niedokrwiennej w okresie 12 miesięcznej terapii.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written consent to participate in the study, expressed prior to any procedures related to the study.
    2. Age 18 and over.
    3. Symptomatic HF in NYHA class II to IV of ischemic etiology at screening visit.
    4. Left ventricular ejection fraction at screening visit ranged from 40-49%, confirmed by echocardiography at a randomization visit.
    5. Elevated concentration of NT-proBNP natriuretic peptide≥125 pg / ml at screening visit(if sinus rhythm during the visit).
    6. Elevated NT-proBNP natriuretic peptide concentration≥350 pg/ml at the screening visit (if atrial fibrillation or flutter during the visit).
    7. Features of a structural / functional disease of the left ventricle.
    8. Optimal pharmacotherapy with ACEI or ARB and beta-blocker, unless they are contraindicated.
    1. Pisemna zgodna na udział w badaniu wyrażona przed przeprowadzeniem jakichkolwiek procedur związanych z badaniem.
    2. Wiek 18 lat i więcej.
    3. Objawowa HF w klasie II do IV wg NYHA o etiologii niedokrwiennej na wizycie przesiewowej.
    4. Frakcja wyrzutowa lewej komory w momencie wizyty przesiewowej w przedziale 40-49%, potwierdzona w badaniu echokardiograficznym na wizycie randomizacyjnej.
    5. Podwyższone stężeniem peptydu natriuretycznego NT-proBNP ≥125 pg/ml na wizycie przesiewowej (jeśli rytm zatokowy w trakcie wizyty).
    6. Podwyższone stężenie peptydu natriuretycznego NT-proBNP≥350 pg/ml na wizycie przesiewowej (jeśli migotanie lub trzepotanie przedsionków w trakcie wizyty).
    7. Cechy strukturalnej/czynnościowej choroby mięśnia lewej komory.
    8. Optymalna farmakoterapia ACEI lub ARB oraz beta-blokerem o ile nie są przeciwwskazane.
    E.4Principal exclusion criteria
    1. History of hypersensitivity or allergy to any of the drugs tested or drugs of similar chemical class, ACEIs, ARBs or neprilysin inhibitors.
    2. Previous history of intolerance to recommended ACEI or ARB target doses.
    3. Known history of angioedema.
    4. Requirement of simultaneous treatment with ACEI and ARB.
    5. Acute decompensated HF within 6 weeks prior to screening visit.
    6. Symptomatic hypotension systolic blood pressure <95 mmHg at screening visit.
    7. Current or previous treatment with sacubitril / valsartan not related to participation in the clinical trial.
    8. Estimated creatinine clearance <30 ml / min / 1,73 m2 at screening visit.
    9. Serum potassium >5.2 mmol / L at screening visit.
    10. Acute coronary syndrome or elective revascularization within 6 weeks prior to screening.
    11. Stroke, transient ischemic attack, carotid angioplasty, heart surgery, or any other major cardiovascular surgery in the 3 months prior to screening.
    12. Implantation of a cardioverter defibrillator, pacemaker, or resynchronization therapy device incompatible with MRI.
    1. Historia nadwrażliwości lub alergii na którykolwiek z badanych leków lub leków podobnych klas chemicznych, ACEI, ARB lub inhibitorów neprylizyny.
    2. Wcześniejsza historia nietolerancji na zalecane dawki docelowe ACEI lub ARB.
    3. Znana historia obrzęku naczynioruchowego.
    4. Wymóg jednoczesnego leczenia ACEI i ARB.
    5. Ostra niewyrównana HF przebyta w ciągu 6 tygodni przed wizytą przesiewową.
    6. Objawowe niedociśnienie skurczowe ciśnienie krwi <95 mmHg na wizycie przesiewowej.
    7. Obecne lub poprzednie leczenie sakubitrylem/walsartanem nie powiązane z udziałem w badaniu.
    8. Szacowany klirens kreatyniny <30 ml/min/1,73m2 podczas wizyty przesiewowej.
    9. Potas w surowicy >5,2 mmol/L podczas wizyty przesiewowej.
    10. Ostry zespół wieńcowy lub planowa rewaskularyzacja przebyte w ciągu 6 tygodni przed wizytą przesiewową.
    11. Udar mózgu, przemijający atak niedokrwienny, angioplastyka tętnic szyjnych, operacja serca lub inne poważne operacje sercowo-naczyniowe w ciągu 3 miesięcy przed wizytą przesiewową.
    12. Wszczepienie kardiowertera defibrylatora, kardiostymulatora lub urządzenia do terapii resynchronizującej niekompatybilnych z MRI.
    E.5 End points
    E.5.1Primary end point(s)
    Change in left ventricular end-systolic volume after 12 months of treatment as measured by MRI.
    Zmiana objętości końcowo-skurczowej lewej komory po 12 miesiącach leczenia zmierzona za pomocą rezonansu magnetycznego.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Randomization visit (W4) and final visit (W9, 12 months after randomization visit).
    Wizyta randomizacyjna (W4) i wizyta końcowa (W9, 12 miesięcy po wizycie randomizacyjnej).
    E.5.2Secondary end point(s)
    1. Change in left ventricular end-diastolic volume measured by MRI in patients with ischemic HFmrEF after 12 months of treatment.
    2. Change in indexed left ventricular end-systolic and end-diastolic volumes measured by MRI in patients with ischemic HFmrEF after 12 months of treatment.
    3. Change in left ventricular ejection fraction measured by MRI in patients with ischemic HFmrEF after 12 months of treatment.
    4. Death from cardiovascular causes or first hospitalization due to HF in patients with ischemic HFmrEF over a 12 month treatment period.
    5. Death from cardiovascular causes or first or subsequent hospitalization due to HF in patients with ischemic HFmrEF over a 12 month treatment period.
    6. Death from cardiovascular causes in patients with ischemic HFmrEF over a 12 month treatment period.
    7. First hospitalization for HF in patients with ischemic HFmrEF over a 12 month treatment period.
    8. First or subsequent hospitalization for HF in patients with ischemic HFmrEF over a 12 month treatment period.
    9. Number of days until death from cardiovascular causes or first hospitalization for HF in patients with ischemic HFmrEF over a 12 month treatment period.
    10. All-cause death in patients with ischemic HFmrEF over a 12 month treatment period.

    Endpoints in the safety assessment:
    1. Development of symptomatic hypotension or with systolic blood pressure <95 mmHg.
    2. Development of hyperkalemia >5.4 mmol / L.
    3. Development of renal failure with eGFR <30 ml / min / 1.73 m2 or exacerbation of renal failure with eGFR decrease compared to visit W1 or W2 by more than 25%.
    1. Zmiana objętości końcowo-rozkurczowej lewej komory zmierzonej metodą MRI u pacjentów z HFmrEF o etiologii niedokrwiennej po 12 miesiącach leczenia.
    2. Zmiana zindeksowanych objętości końcowo-skurczowej i końcowo-rozkurczowej lewej komory zmierzonych metodą MRI u pacjentów z HFmrEF o etiologii niedokrwiennej po 12 miesiącach leczenia..
    3. Zmiana frakcji wyrzutowej lewej komory zmierzonej metodą MRI u pacjentów z HFmrEF o etiologii niedokrwiennej po 12 miesiącach leczenia.
    4. Zgon z przyczyn sercowo-naczyniowych lub pierwsza hospitalizacja z powodu HF u pacjentów z HFmrEF o etiologii niedokrwiennej w okresie 12 miesięcznej terapii.
    5. Zgon z przyczyn sercowo-naczyniowych lub pierwsza lub kolejna hospitalizacja z powodu HF u pacjentów z HFmrEF o etiologii niedokrwiennej w okresie 12 miesięcznej terapii.
    6. Zgon z przyczyn sercowo-naczyniowych u pacjentów z HFmrEF o etiologii niedokrwiennej w okresie 12 miesięcznej terapii.
    7. Pierwsza hospitalizacja z powodu HF u pacjentów z HFmrEF o etiologii niedokrwiennej w okresie 12 miesięcznej terapii.
    8. Pierwsza lub kolejna hospitalizacja z powodu HF u pacjentów z HFmrEF o etiologii niedokrwiennej w okresie 12 miesięcznej terapii.
    9. Liczba dni do wystąpienia zgonu z przyczyn sercowo-naczyniowych lub pierwszej hospitalizacji z powodu HF u pacjentów z HFmrEF o etiologii niedokrwiennej w okresie 12 miesięcznej terapii.
    10. Zgon z jakiejkolwiek przyczyny u pacjentów z HFmrEF o etiologii niedokrwiennej w okresie 12 miesięcznej terapii.

    Punkty końcowe w ocenie bezpieczeństwa:
    1. Wystąpienie hipotonii objawowej lub z ciśnieniem skurczowym <95 mmHg.
    2. Wystąpienie hiperkaliemii >5.4 mmol/L.
    3. Wystąpienie niewydolności nerek z eGFR <30 ml/min/1.73 m2 lub zaostrzenie niewydolności nerek ze spadkiem eGFR w stosunku do wizyty W1 lub W2 o więcej niż 25%.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Endpoints 1-3 - at randomization visit (W4) and final visit (W9, 12 months after randomization visit)
    Endpoints 4-10 - throughout the whole study period
    Endpoints in the safety assessment - at all visits except the screening visit
    Punkty końcowe 1-3 - wizyta randomizacyjna (W4) i wizyta końcowa (W9, 12 miesięcy po wizycie randomizacyjnej)
    Punkty końcowe 4-10 – przez cały okres badania
    Punkty końcowe w ocenie bezpieczeństwa – wszystkie wizyty poza wizytą screeningową
    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 Yes
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    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) Yes
    E.8.2.2Placebo No
    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 concerned5
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 466
    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 state666
    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
    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 Decision2023-01-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-02
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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