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    Summary
    EudraCT Number:2018-003441-42
    Sponsor's Protocol Code Number:D169EC00001
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-11-10
    Trial results View 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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2018-003441-42
    A.3Full title of the trial
    An International, Multicentre, Parallel-group, Randomised, Double-blind, Placebo-controlled, Phase III Study Evaluating the effect of Dapagliflozin on Exercise Capacity in Heart Failure Patients with Preserved Ejection Fraction (HFpEF)
    Studio di fase III internazionale, multicentrico, randomizzato a gruppi paralleli, in doppio cieco, controllato con placebo per valutare l’effetto di Dapagliflozin sulla capacità di esercizio fisico in pazienti affetti da insufficienza cardiaca con Frazione di Eiezione conservata (HFpEF)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    DETERMINE-preserved – Dapagliflozin EffecT on ExeRcise capacity using a 6-MINutE walk test in patients with heart failure with preserved ejection fraction A
    DETERMINE- conservata - Effetto di Dapagliflozin sulla capacità di esercizio usando il test della distanza percorsa in 6 minuti in pazienti con insufficienza cardiaca con frazione di eiezione conservata
    A.3.2Name or abbreviated title of the trial where available
    DETERMINE-preserved
    DETERMINE-conservata
    A.4.1Sponsor's protocol code numberD169EC00001
    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 SponsorASTRAZENECA AB
    B.1.3.4CountrySweden
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAstraZeneca
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street Addressna
    B.5.3.2Town/ cityna
    B.5.3.3Post codena
    B.5.3.4CountryUnited States
    B.5.6E-mailinformation.center@astrazeneca.com
    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 No
    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 nameDapaglifloxin
    D.3.2Product code [-]
    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 INNDAPAGLIFLOZIN
    D.3.9.1CAS number 960404-48-2
    D.3.9.2Current sponsor code-
    D.3.9.3Other descriptive nameDAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Heart Failure Patients with Preserved Ejection Fraction (HFpEF)
    Pazienti con insufficienza cardiaca con frazione di eiezione conservata (HFpEF)
    E.1.1.1Medical condition in easily understood language
    Heart Failure with preserved pump function to eject blood flow
    Insufficienza cardiaca con funzione di pompa preservata per espellere il flusso sanguigno
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10076396
    E.1.2Term Heart failure with preserved ejection fraction
    E.1.2System Organ Class 100000004849
    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 whether dapagliflozin is superior to placebo in patients with chronic heart failure with New York Heart Association (NYHA) Functional Class II-IV (range I-IV, higher class represents worse functional class) and preserved ejection fraction (LVEF>40%) in
    - reducing patient-reported HF symptoms
    - reducing patient-reported physical limitation
    - improving exercise capacity
    Determinare se dapagliflozin sia superiore al placebo in pazienti con insufficienza cardiaca cronica in classe funzionale NYHA II-IV (intervallo I-IV, la classe superiore rappresenta la classe funzionale peggiore) e frazione di eiezione conservata (LVEF >40%) [HFpEF] nel:
    - ridurre i sintomi dell’insufficienza cardiaca (HF) riportati dai pazienti
    - ridurre la limitazione fisica riportata dai pazienti
    - migliorare la capacità di esercizio
    E.2.2Secondary objectives of the trial
    To determine whether dapagliflozin is superior to placebo in increasing time spent non-sedentary, evaluated in a subset at least 100 patients.
    Determinare se dapagliflozin sia superiore al placebo nell’aumentare il tempo speso non sedentariamente valutato in un sottogruppo di almeno 100 pazienti.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provision of signed informed consent prior to any study specific procedures
    2. Male or female, aged = 40 years
    3. Documented diagnosis of symptomatic HF (NYHA functional class II-IV), which has been present for at least 8 weeks, optimally treated with pharmacotherapy and/or device therapy with at least intermittent need for diuretic treatment.
    4. LVEF >40% and evidence of structural heart disease documented by the most recent echocardiogram, or cardiac magnetic resonance imaging within the last 12 months prior to enrolment.
    5. NT-proBNP = 250 pg/mL at Visit 1 for patients without ongoing atrial fibrillation/flutter. If a trial fibrillation/flutter is present at Visit 1, NTproBNP must be =500 pg/mL.
    6. Patients should receive background standard of care as described below: All patients will be treated according to locally recognised guidelines on standard of care treatment for patients with HFpEF. Therapy should have been individually optimised and stable for = 4 weeks (this does not apply to diuretics) and include (unless contraindicated or not tolerated) treatment of co morbidities (including high blood pressure, ischaemic heart disease, atrial fibrillation/flutter).
    7. 6MWD =100 metres and = 425 metres at both the Enrolment and Randomisation.
    1. rilascio del consenso informato firmato prima di qualsiasi procedura studio-specifica
    2. maschio o femmina con età = 40 anni
    3. diagnosi documentata di insufficienza cardiaca cronica (classe funzionale NYHA II-IV), presente da almeno 8 settimane, trattata con terapia famacologica e/o con dispositivo con necessità almeno intermmitente di trattamento diuretico
    4.LVEF >40% ed evidenza di cardiopatia strutturale documentata dal più recente ecocardiogramma, o dal risonanza magnetica cardiaca nelgli ultimi 12 mesi prima dell'arruolamento
    5. NT-proBNP = 250 pg/mL alla Visita 1 per pazienti senza fibrillazione/flutter atriale in corso. Se è presente fibrillazione/flutter atriale alla visita 1, NTproBNP deve essere =500 pg/mL
    6. I pazienti dovrebbero ricevere terapia standard di background come descritto di seguito: tutti i pazienti saranno trattati secondo le linee guida localmente riconosciute per il trattamento standard di pazienti con HFpEF. La terapia dovrebbe essere ottimizzata per ogni individuo e stabile per =4 settimane ( ciò non è applicabile per i diuretici) e dovrebbe includere (a meno che non sia controindicato o non tollerato) il trattamento di co-morbidità (comprese pressione sanguigna alta, cardiopatia ischemica, fibrillazione atriale/flutter)
    7.6MWD =100 metri e =425 metri sia all'arruolamento sia alla randomizzazione
    E.4Principal exclusion criteria
    1. Presence of any condition that precludes exercise testing.
    2. Participation in a structured exercise training programme in the 1 month prior to screening or planned to start during the trial.
    3. Receiving therapy with an SGLT2 inhibitor within 4 weeks prior to randomisation or previous intolerance to an SGLT2 inhibitor.
    4. Type 1 diabetes mellitus.
    5. eGFR <25 mL/min/1.73 m2 (CKD-EPI formula) at visit 1, unstable or rapidly progressing renal disease at time of randomisation.
    6. Systolic BP <95 mmHg on 2 consecutive measurements at 5-minute intervals, at Visit 1 or at Visit 2a/b.
    7. Systolic BP=160 mmHg if not on treatment with =3 blood pressure lowering medications or =180 mmHg irrespective of treatments, on 2 consecutive measurements at 5-minute intervals, at Visit 1 (Enrolment) or at Visit 2a/b
    8. Current acute decompensated HF or hospitalisation due to decompensated HF <4 weeks prior to enrolment.
    9. Myocardial infarction, unstable angina, coronary revascularization ablation of atrial fibrillation/flutter, valve repair/replacement, implantation of a cardiac resynchronization therapy device within 12 weeks prior to enrolment.
    10. Planned coronary revascularization, ablation of atrial fibrillation/flutter and/or valve repair/replacement.
    11. Stroke or transient ischemic attack within 12 weeks prior to enrolment.
    12. Probable alternative or concomitant diagnoses which could account for the patient's HF symptoms and signs.
    13. Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including COPD.
    14. Previous cardiac transplantation, or complex congenital heart disease. Planned cardiac resynchronisation therapy. Prior implantation of a ventricular assistance device or similar device, or implantation expected after randomization.
    15. HF due to any of the following: known infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, known genetic hypertrophic cardiomyopathy or obstructive hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy/dysplasia, or uncorrected primary valvular disease.
    16. A life expectancy of <2 years due to any non-cardiovascular condition, based on Investigator's clinical judgement.
    17. Active malignancy requiring treatment (with the exception of basal cell or squamous cell carcinomas of the skin).
    18. Acute or chronic liver disease with severe impairment of liver function (eg, ascites, oesophageal varices, coagulopathy).
    19. Women of child-bearing potential not willing to use a medically accepted method of contraception considered reliable in the judgment of the Investigator OR who have a positive urine pregnancy test at randomisation OR who are breast-feeding.
    20. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca personnel and/or personnel at the study site).
    21. Previous randomisation in the present study.
    22. Participation in another clinical study with an IP or device during the last month prior to enrolment.
    23. Inability of the patient, in the opinion of the Investigator, to understand and/or comply with studwith study medications, procedures and/or follow-up (especially completing ePRO assessments) OR any conditions that, in the opinion of the Investigator, may render the patient unable to complete the study. Therefore, patients who are unable to read (eg, are blind or illiterate) should be excluded from participating in this trial.
    1. Presenza di qualsiasi condizione che precluda l’esercizio di prova
    2. Partecipazione ad un programma di allenamento strutturato nel mese antecedente lo screening o il cui inizio è pianificato dirante lo studio
    3. Assunzione di terapia con inibitori di SGLT2 nelle 4 settimane antecedenti la randomizzazione o precedenti intolleranze a inibitori di SGLT2
    4. Diabete mellito di tipi I
    5. eGFR <25 mL/min/1.73 m2 (formula CKD-EPI) alla visita 1, con insufficienza renale instabile o in rapida progressione al momento della randomizzazione
    6. pressione sanguigna sistolica <95 mmHg su due misurazioni consecutive con intervallo di 5 minuti, alla visita 1 o alla visita 2a/b
    7. pressione sanguigna sistolica=160 mmHg se non in trattamento con=3 farmaci per abbassare la pressione oppure =180 mmHg indipendentemente dal trattamento, con due misurazioni consecutive con un intervallo di 5 minuti, alla visita 1(arruolamento) o 2a/b
    8. insufficienza cardiaca acuta decompensata in corso o ospedalizzazione dovuta a insufficienza cardiaca decompensata <4 settimane prima dell’arruolamento
    9. infarto del miocardio, angina instabile, ablazione della rivascolarizzazione coronarica della fibrillazione/flutter atriale, riparazione/sostituzione di valvole, impianto di un dispositivo di terapia di risincronizzazione cardiaca entro 12 settimane prima dell'arruolamento
    10. rivascolarizzazione coronarica programmata ablazione del fibrillazione/flutter atriale e/o sostituzione/riparazione di valvole.
    11. Infarto o attacco isterico transiente nelle 12 settimane antecedenti l’arruolamento
    12. Probabili diagnosi alternative o concomitanti che potrebbero spiegare i sintomi e segni dell’insufficienza cardiaca del paziente
    13. Ipertensione polmonare primitiva, embolia polmonare cronica, grave malattia polmonare inclusa BPCO.
    14. Precedente trapianto cardiaco o cardiopatia congenita complessa. Terapia di risincronizzazione cardiaca programmata. Precedente impianto di dispositivo di assistenza ventricolare o simile, oppure impianto programmato dopo l’arruolamento
    15. Insufficienza cardiaca dovuta ad una qualsiasi delle seguenti condizioni: cardiomiopatia infiltrativa nota, miocardite attiva, pericardite costrittiva, tamponamento cardiaco, cardiomiopatia ipertrofica genetica, oppure cardiomiopatia ipertrofica ostruttiva, cardiomiopatia/displasia aritmogenica ventricolare destra o malattia valvolare primaria non corretta
    16. Aspettativa di vita <2 anni a causa di qualsiasi condizione non cardiovascolare, basata sul giudizio clinico dello sperimentatore.
    17. Neoplasia attiva che richiede un trattamento (ad eccezione di carcinomia cellule basali o squamose della pelle)
    18. Malattia epatica acuta o cronica con grave compromissione della funzionalità epatica (es. Ascite, varici esofagee, coagulopatia)
    19. Le donne in età fertile che non sono disposte a utilizzare un metodo contraccettivo accettato dal punto di vista medico sono considerate affidabili nel giudizio dello sperimentatore O che hanno un test di gravidanza positivo delle urine durante la randomizzazione o che allattano al seno.
    20. Coinvolgimento nella pianificazione e / o nella conduzione dello studio (vale sia per il personale di AstraZeneca che per il personale del sito di studio).
    21. Precedente randomizzazione nel presente studio.
    22. Partecipazione a un altro studio clinico con un IP o un dispositivo durante l'ultimo mese prima dell'iscrizione.
    23. Incapacità del paziente, secondo il parere dello sperimentatore, di comprendere e / o conformarsi allo studio con i farmaci, le procedure e / o il follow-up dello studio (in particolare il completamento delle valutazioni ePRO) O qualsiasi condizione che, secondo il parere dello sperimentatore, può rendere il paziente incapace di completare lo studio. Pertanto, i pazienti che non sono in grado di leggere (ad esempio, ciechi o analfabeti) dovrebbero essere esclusi dalla partecipazione a questo studio.
    E.5 End points
    E.5.1Primary end point(s)
    -Change from baseline in Kansas-City Cardiomyopathy Questionnaire- Total Symptom Score (KCCQ-TSS) at Week16 (higher scores represent less HF symptom frequency and burden).
    - Change from baseline in Kansas-City Cardiomyopathy Questionnaire- Physical Limitation Score (KCCQ-PLS) at Week16 (higher scores represent less physical limitation due to HF)
    - Change from baseline in 6-minute walk distance (6MWD) at Week16 (larger distances represent better functional capacity).
    -Variazione dal baseline nel punteggio totale dei sintomi nel questionario Kansas City Cardiomyopathy (KCCQ-TSS) alla 16ma settimana (i punteggi più alti rappresentano una frequenza e un carico dei sintomi ridotti dello scompenso cardiaco).
    - Variazione dal baseline nel punteggio sulla limitazione fisica nel questionario sulla cardiomiopatia di Kansas City (KCCQ-PLS) alla 16ma settimana (i punteggi più alti rappresentano una limitazione fisica minore a causa dell'HF)
    - Variazione dal baseline nel test 6-minute walk distance (6MWD) alla 16ma settimana (distanze maggiori rappresentano una migliore capacità funzionale).
    E.5.1.1Timepoint(s) of evaluation of this end point
    At baseline and at Week 16
    Dal baseline e alla 16ma settimana
    E.5.2Secondary end point(s)
    Change from baseline at the end of the study in the total time spent in light to vigorous physical activity, as assessed using a wearable activity monitor (accelerometer).
    Variazione dal baseline fino alla fine dello studio del tempo totale trascorso effettuando attività fisica da leggera a intensa, usando un monitor indossabile dell’attività (accelerometro)
    E.5.2.1Timepoint(s) of evaluation of this end point
    From baseline until the week starting at Week14
    Dal baseline fino all'inizio della 14ma settimana
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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) 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA34
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Brazil
    Bulgaria
    Canada
    Denmark
    Italy
    Japan
    Korea, Democratic People's Republic of
    Slovakia
    South Africa
    Sweden
    United States
    E.8.7Trial has a data monitoring committee No
    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
    Last visit of the Last subject
    ultima visita dell'ultimo paziente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial 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: 250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 250
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 185
    F.4.2.2In the whole clinical trial 500
    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
    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 Decision2019-05-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-18
    P. End of Trial
    P.End of Trial StatusCompleted
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