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    Summary
    EudraCT Number:2022-000420-38
    Sponsor's Protocol Code Number:2021-01755
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2023-05-23
    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 ConcernedGermany - BfArM
    A.2EudraCT number2022-000420-38
    A.3Full title of the trial
    Dapagliflozin in patients with Right Heart Failure (Dapa-RHF)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Dapagliflozin in patients with Right Heart Failure (Dapa-RHF)
    A.3.2Name or abbreviated title of the trial where available
    DAPA-RHF
    A.4.1Sponsor's protocol code number2021-01755
    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 SponsorUniversitätsmedizin Göttingen
    B.1.3.4CountryGermany
    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 GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation Universitätsmedizin Göttingen
    B.5.2Functional name of contact pointPrincipal Investigator
    B.5.3 Address:
    B.5.3.1Street AddressRobert-Koch-Str. 40
    B.5.3.2Town/ cityGöttingen
    B.5.3.3Post code 37075
    B.5.3.4CountryGermany
    B.5.4Telephone number+4955139 20912
    B.5.5Fax number+4955139 20918
    B.5.6E-mailstephan.von.haehling@med.uni-goettingen.de
    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 FORXIGA
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca GmbH
    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.3.1Product nameDapagliflozin
    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.3.9.4EV Substance CodeSUB31650
    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 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
    Right heart failure defined as (criteria a-c must all be fulfilled):
    a) Reduced right ventricular systolic function or RV strain defined as at least one of the following
    b) N-terminal pro-BNP (NT-proBNP) >125 pg/ml
    c) Clinical signs of right cardiac congestion or need for diuretic therapy to prevent signs of congestion
    E.1.1.1Medical condition in easily understood language
    Dysfunction of the right heart structures (right ventricle, tricuspid valve apparatus and right atrium) resulting in impaired ability of right heart to perfuse lungs at normal central venous pressures
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate that dapagliflozin on top of standard of care is superior in reducing the primary outcome in patients with chronic RHF compared to standard of care plus placebo.
    E.2.2Secondary objectives of the trial
    To investigate the influence of dapagliflozin in patients with chronic right heart failure on secondary outcomes as changes in quality of life, right ventricular ejection fraction, exercise capacity, NYHA class, cardiac imaging parameters, renal function or laboratory parameters
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. The Patient is willing and able to participate and provide written informed consent;
    2. Age ≥ 18 years and < 90 years;
    3. Presence of RHF defined as (criteria a-c must all be fulfilled):
    a) Reduced right ventricular systolic function or RV strain defined as at least one of the following
    - tricuspid annular plane systolic excursion (TAPSE) <16 mm
    - RV fractional area change (FAC) <35%
    - Systolic pulmonary artery pressure (PAP sys) ≥35 mmHg combined with an extended inferior vena cava (>2,1 cm) with reduced collapsibility (<50%) during sniff inspiration assessed in echocardiography

    b) N-terminal pro-BNP (NT-proBNP) >125 pg/ml

    c) Clinical signs of right cardiac congestion (edema, and / or extended inferior vena cava (>2,1 cm) with reduced collapsibility (<50%) during sniff inspiration assessed in echocardiography and / or pleural effusion on sonography and / or chest radiograph) or need for diuretic therapy to prevent signs of congestion

    4. For women of childbearing potential (until 1 year after menopause):
    a) Negative pregnancy test AND
    b) Use of highly effective methods of contraception during treatment plus 5 days after the end of study drug administration
    E.4Principal exclusion criteria
    1. Heart failure with reduced left ventricular (LV) ejection fraction (LVEF <40%)
    2. Pulmonary arterial hypertension (PAH, PH Group I)
    3. Acute (within 30 days) pulmonary embolism
    4. Acute (within 30 days) right ventricular myocardial infarction
    5. Current medication with any SGLT2 inhibitor
    6. Chronic kidney disease (CKD) or acute kidney injury with eGFR < 25 ml/min/1,73 m², or end-stage renal failure with the need for chronic dialysis treatment
    7. Systolic blood pressure (SBP) <90 mmHg at randomization on 2 consecutive measurements
    8. Any contraindication for cardiac magnetic resonance imaging (MRI)
    9. Known intolerance or hypersensitivity to dapagliflozin
    10. Known contraindication for the treatment with dapagfliflozin
    11. Type 1 diabetes mellitus
    12. Incapacity to understand the nature, significance and implications of the clinical trial and / or to provide written informed consent
    13. Current participation in another interventional trial
    14. Pregnancy or lactating women
    E.5 End points
    E.5.1Primary end point(s)
    Change in serum NT-proBNP level from baseline to end of treatment (Delta-NT-proBNP)
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of treatment
    (week 12 and week 24)
    E.5.2Secondary end point(s)
    Four key secondary endpoints of equal importance have been defined:

    1.) Change in quality of life assessed by overall summary score of the Kansas City Cardiomyopathy Questionnaire (KCCQ) (a specific HF patient reported outcome questionnaire) from baseline to end of treatment
    2.) Change in RV ejection fraction (RV EF) [%] assessed in cardiac MRI from baseline to end of treatment
    3.) Change in exercise capacity assessed by the 6 min walking distance [meters] from baseline to end of treatment
    4.) Change in NYHA class from baseline to end of treatment

    Other secondary endpoints
    1.) Imaging secondary endpoints
    a. Cardiac MRI
    - Change in RV global strain and right atrial long-axis strain (LAS) on cardiac MRI
    - Number of patients with an improvement in RV EF (assessed on cardiac MRI)
    b. Echocardiography
    - Change in TAPSE (mm)
    - Change in PAPsys (mmHg) assessed in echocardiography
    - Number of patients with decrease in PAP sys ≥5 mmHg while TAPSE is at least stable
    2.) Renal secondary endpoints
    - Change in renal arterial and venous flow parameters (as assessed by ultrasound sonography):
    ~ arterial flow: renal resistance index (RRI)
    ~ venous flow: venous flow pattern, venous impedance index (VII), renal venous stasis index
    (RVSI), venous velocity index (VVI)
    - Change in urine albumin and protein level
    - Change in serum levels of creatinine, eGFR
    - Number of patients with worsening renal function (WRF), defined as ≥0.3 mg/dl increase of
    serum creatinine and / or ≥10 % decrease of eGFR
    - Change in fractional excretion of sodium and urea
    - number of patients with predominance of diastolic flow of the liver vein [defined as VS/(VS + VD)
    < 55%]
    3.) Laboratory secondary endpoints
    - Number of patients with ≥30% decrease of NT-proBNP level
    - Change in Alanine-Aminotransferase (ALAT) level
    4.) Clinical secondary endpoints
    - Change in dyspnoea level assessed by visual analogue scale
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of treatment
    (week 12 and week 24)
    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 No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    E.8.1.6Cross over Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months2
    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: 26
    F.1.3Elderly (>=65 years) Yes
    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 No
    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 state26
    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 Decision2023-05-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-09-18
    P. End of Trial
    P.End of Trial StatusOngoing
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