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    Summary
    EudraCT Number:2018-002614-12
    Sponsor's Protocol Code Number:ESR-17-13447(DAPA-HF)
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-01-18
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2018-002614-12
    A.3Full title of the trial
    Short-term Effects of Dapagliflozin on Peak VO2 in Patients with Heart Failure with Reduced Ejection Fraction and Type 2 Diabetes
    Efectos a corto plazo de la dapagliflozina en el consumo pico de oxígeno en pacientes diabéticos tipo 2 con insuficiencia cardíaca con función sistólica reducida.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    DAPA-HF
    DAPA-HF
    A.4.1Sponsor's protocol code numberESR-17-13447(DAPA-HF)
    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 SponsorInstituto de Investigación Sanitaria INCLIVA
    B.1.3.4CountrySpain
    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 supportASTRAZENECA FARMACÉUTICA SPAIN S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstituto de Investigación Sanitaria INCLIVA
    B.5.2Functional name of contact pointScientific Subdirector
    B.5.3 Address:
    B.5.3.1Street AddressAvd. Menendez Pelayo 4 acc
    B.5.3.2Town/ cityValencia
    B.5.3.3Post code46010
    B.5.3.4CountrySpain
    B.5.4Telephone number0034961973976
    B.5.5Fax number0034961973976
    B.5.6E-mailgestioncientifica@incliva.es
    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.2.1.2Country which granted the Marketing AuthorisationSpain
    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 INNDAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE
    D.3.9.1CAS number 960404-48-2
    D.3.9.3Other descriptive nameDAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE
    D.3.9.4EV Substance CodeSUB90205
    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 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 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
    Stable symptomatic heart failure with reduced ejection fraction (HFrEF)
    Insuficiencia cardíaca sintomática estable con fracción de eyección reducida (HFrEF)
    E.1.1.1Medical condition in easily understood language
    Stable symptomatic heart failure
    Insuficiencia cardíaca sintomática estable
    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 HLGT
    E.1.2Classification code 10019280
    E.1.2Term Heart failures
    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 and quantify the changes in peakVO2 at 30 and 90 days after starting treatment with dapagliflozin vs. placebo.
    Determinar y cuantificar los cambios en el picoVO2 a los 30 y 90 días después de comenzar el tratamiento con dapagliflozina vs. Placebo.
    E.2.2Secondary objectives of the trial
    To quantify changes in 6MWT, MLHFQ, surrogates of HF severity [amino-terminal pro-brain natriuretic peptide (NT-proBNP), high-sensitivity troponin T (hs-TnT), ST-2, and galectin-3], markers of congestion (clinical signs, plasma CA125, bioimpedance, and renal echo doppler), urine biomarkers (tubule markers, serum sodium, serum potassium, and glucose), and metabolomics (determination of ketones), at 30 and 90 days after the initiation of dapagliflozin vs. placebo.
    Cambios en el test de la marcha de los seis minutos (6MWT), en la puntuación en el cuestionario de calidad de vida (MLHFQ), en marcadores de severidad de insuficiencia cardiaca [fracción amino-terminal del pro-péptido natriurético cerebral (NT-proBNP), Troponina T de alta sensibilidad (hs-TnT) y Galectina-3], en marcadores de congestión [signos clínicos, antígeno carbohidrato 125 (CA125), bioimpedancia y eco doppler], en biomarcadores en orina (marcadores de túbulos, sodio, potasio y glucosa), en biomarcadores metabólicos (determinación de cuerpos cetónicos en plasma), a los 30 y 90 días después del inicio de la administración de dapagliflozina verUS placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -The participant or his legal representative is willing and able to give informed consent for participation in the study.
    - Male or female, aged ≥18 years.
    - Established documented diagnosis of symptomatic HF (NYHA functional class II-III), which has been present for at least 2 months.
    - LVEF ≤40% documented in the last 3 months by echocardiography or cardiac magnetic resonance.
    - Established diagnosis of type 2 diabetes.
    - NT-proBNP ≥600 pg/ml.
    - Patients should receive background standard of care for HFrEF at judgment of the investigator.
    - Estimated glomerular filtration rate (eGFR) ≥30 ml/min/1.73m2 (DMRD formula) at enrolment.
    - El participante o su representante legal está dispuesto y puede dar su consentimiento informado para participar en el estudio.
    - Hombre o mujer, edad ≥ 18 años.
    - Se estableció un diagnóstico documentado de IC sintomática (clase funcional II-III de la NYHA), que ha estado presente durante al menos 2 meses.
    - FEVI ≤40% documentado en los últimos 3 meses mediante ecocardiografía o resonancia magnética cardíaca.
    - Establecido diagnóstico de diabetes tipo 2.
    - NT-proBNP ≥600 pg / ml
    - Los pacientes deben recibir un tratamiento de fondo estándar para la HFrEF a juicio del investigador
    - Tasa estimada de filtración glomerular (eGFR) ≥30 ml / min / 1.73m2 (fórmula DMRD) al momento de la aleatorizacion.
    E.4Principal exclusion criteria
    - Patients receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment, or previous intolerance of an SGLT2 inhibitor.
    - Type 1 diabetes.
    - Symptomatic hypotension or systolic blood pressure <95 mmHg.
    - Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment.
    - Myocardial infarction, unstable angina, stroke, or transient ischemic attack within 12 weeks prior to enrolment.
    - Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or cardiac valve repair/replacement within 12 weeks prior to enrolment, or planned to undergo any of these operations after randomization.
    - Implantation of a cardiac resynchronization therapy (CRT) device within 12 weeks prior to enrolment or intent to implant a CRT device.
    - Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization.
    - HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy, or uncorrected severe primary cardiac valve disease.
    - Symptomatic bradycardia or second or third-degree heart block without a pacemaker.
    - Severe renal dysfunction (eGFR<30 ml/min/1.73m2) or prior admission for acute renal failure in the last 4 weeks.
    - Pregnant or lactating women.
    - Woman of childbearing age, unless they are using highly effective contraceptive methods.
    - Patients with severe hepatic impairment (Child-Pugh class C).
    - Pacientes que reciben terapia con un inhibidor de SGLT2 dentro de las 8 semanas anteriores a la aleatorizacion o intolerancia previa a un inhibidor de SGLT2.
    - Diabetes tipo 1.
    - Hipotensión sintomática o presión arterial sistólica <95 mmHg.
    - IC actual descompensada aguda u hospitalización debido a IC descompensada <4 semanas antes de la aleatorizacion .
    - Infarto de miocardio, angina inestable, accidente cerebrovascular o ataque isquémico transitorio dentro de las 12 semanas anteriores a la aleatorizacion .
    - Revascularización coronaria (intervención coronaria percutánea o injerto de derivación de la arteria coronaria) o reparación / reemplazo de la válvula cardíaca dentro de las 12 semanas anteriores a la aleatorizacion, o se planea someterse a alguna de estas operaciones después de la aleatorización.
    - Implantación de un dispositivo de terapia de resincronización cardíaca (TRC) dentro de las 12 semanas anteriores a la aleatorizacion o la intención de implantar un dispositivo de TRC.
    - Trasplante cardíaco anterior o implantación de un dispositivo de asistencia ventricular o dispositivo similar, o implantación prevista después de la aleatorización.
    - IC debido a cardiomiopatía restrictiva, miocarditis activa, pericarditis constrictiva, cardiomiopatía hipertrófica (obstructiva) o enfermedad grave de la válvula cardíaca no corregida.
    - Bradicardia sintomática o bloqueo cardíaco de segundo o tercer grado sin marcapasos.
    - Disfunción renal grave (eGFR <30 ml / min / 1.73m2) o ingreso previo por insuficiencia renal aguda en las últimas 4 semanas.
    - Mujeres embarazadas o lactantes.
    - Mujeres en edad fértil, a menos que estén usando métodos anticonceptivos altamente efectivos.
    - Pacientes con insuficiencia hepática grave (clase C de Child-Pugh).
    E.5 End points
    E.5.1Primary end point(s)
    Changes in peakVO2.
    Cambios en el picoVO2.
    E.5.1.1Timepoint(s) of evaluation of this end point
    at 30 and 90 days after starting treatment with dapagliflozin vs. placebo.
    a los 30 y 90 días después de comenzar el tratamiento con dapagliflozina vs. Placebo.
    E.5.2Secondary end point(s)
    Changes in 6MWT, MLHFQ, surrogates of HF severity [amino-terminal pro-brain natriuretic peptide (NT-proBNP), high-sensitivity troponin T (hs-TnT), ST-2, and galectin-3], markers of congestion (clinical signs, plasma CA125, bioimpedance, and renal echo doppler), urine biomarkers (tubule markers, serum sodium, serum potassium, and glucose), and metabolomics (determination of ketones).
    Cambios en el test de la marcha de los seis minutos (6MWT), en la puntuación en el cuestionario de calidad de vida (MLHFQ), en marcadores de severidad de insuficiencia cardiaca [fracción amino-terminal del pro-péptido natriurético cerebral (NT-proBNP), Troponina T de alta sensibilidad (hs-TnT) y Galectina-3], en marcadores de congestión [signos clínicos, antígeno carbohidrato 125 (CA125), bioimpedancia y eco doppler], en biomarcadores en orina (marcadores de túbulos, sodio, potasio y glucosa), en biomarcadores metabólicos (determinación de cuerpos cetónicos en plasma).
    E.5.2.1Timepoint(s) of evaluation of this end point
    At 30 and 90 days after the initiation of dapagliflozin vs. placebo.
    A los 30 y 90 días después del inicio de la administración de dapagliflozina verus placebo.
    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 No
    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 concerned3
    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 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 participant (LVLS)
    Ultima visita del ultimo participante
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months18
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    PARTICIPANT OR HIS LEGAL REPRESENTATIVE IS WILLING AND ABLE TO GIVE INFORMED CONSENT FOR PARTICIPATION IN THE STUDY
    EL PARTICIPANTE O SU REPRESENTANTE LEGAL ESTA DISPUESTO Y ES CAPAZ DE DAR SU CONSENTIMIENTO INFORMADO PARA LA PARTICIPACIÓN EN EL ESTUDIO
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state90
    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)
    At the final visit of the study [Visit 3 (90 ± 3 days)], patients will be asked to return the medication left over from the study, the results of the study will be carefully explained and the doctor will continue with the treatment of the patients following the practice usual clinic of the center. A telephone contact will be made 30 days after the end of the treatment. This call will be made to exclude the possibility of adverse effects after the completion of the study.
    En la visita final del estudio [Visita 3 (90 ± 3 días)], se solicitara a los pacientes que devuelvan la medicación sobrante del estudio, se explicaran detenidamente los resultados del estudio y el medico continuará con el tratamiento de los pacientes siguiendo la práctica clínica habitual del centro. Se realizará un contacto telefónico 30 días después del final del tratamiento. Esta llamada se realizará para excluir la posibilidad de efectos adversos después de la finalización del estudio.
    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 Decision2019-02-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-01-31
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-01-31
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