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    Summary
    EudraCT Number:2021-003674-32
    Sponsor's Protocol Code Number:ULRICA-PILOT
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-10-28
    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 ConcernedSweden - MPA
    A.2EudraCT number2021-003674-32
    A.3Full title of the trial
    A pilot study to evaluate the safety and efficacy of SGLT2 inhibitors in patients with cardiac amyloidosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A pilot study to evaluate the safety and efficacy of SGLT2 inhibitors in patients with cardiac amyloidosis
    A.4.1Sponsor's protocol code numberULRICA-PILOT
    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 SponsorRegion Västerbotten
    B.1.3.4CountrySweden
    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 supportRegion Västerbotten
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportUmeå University
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportHjärt- Lungfonden
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUmeå University
    B.5.2Functional name of contact pointSponsor, Coordinating Investigator
    B.5.3 Address:
    B.5.3.1Street AddressDepartment of Public Health and Clinical Medicine, Umeå University
    B.5.3.2Town/ cityUmeå
    B.5.3.3Post code90187
    B.5.3.4CountrySweden
    B.5.4Telephone number+4670288 82 85
    B.5.6E-mailkrister.lindmark@umu.se
    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 AB
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 nameForxiga
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with cardiac amyloidosis.
    E.1.1.1Medical condition in easily understood language
    Patients with cardiac amyloidosis.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary objective: Assess impact of dapagliflozin on NT-proBNP levels in patients with optimally treated cardiac ATTR amyloidosis
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are:
    • determine whether dapagliflozin reduces patient-reported HF symptoms in patients with optimally treated cardiac ATTR amyloidosis.
    • assess whether dapagliflozin improves walking distance at 6MWT in patients with cardiac ATTR amyloidosis
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria:
    • Established diagnosis of ATTRv or ATTRwt amyloidosis verified by either:
    1. Tissue biopsy with ATTR amyloid deposits
    OR
    2. DPD scintigraphy with Perugini scale grade II or III cardiac uptake and absence of monoclonal bands in serum and urine electrophoresis and normal free light chain assay ruling out AL amyloidosis.
    • Clinical diagnosis of HF according to ESC criteria for diagnosing HF with symptoms of heart failure and a left ventricular ejection fraction of <50%, or echocardiographic signs of diastolic dysfunction according to ESC criteria.
    • NYHA-class II-IV
    • Intraventricular septum diameter >12 mm
    • DPD scintigraphy uptake in the myocardium Perugini scale grade II or III
    • Optimal treated and stable HF and ATTR amyloidosis for at least four weeks, according to the treating physician.
    • Genetic testing is performed on all patients to determine diagnosis of ATTRwt or ATTRv
    • Age ≥ 18
    • TTE performed withing 12 months of screening visit.
    • Women of Childbearing Capacity (WOCBC) must comply to use of highly effective contraception methods during the trial. Acceptable methods according to CTFG guidelines are combined hormonal contraception (oral, dermal, intravaginal), progesterone-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), an intrauterine device, an intrauterine hormone-releasing system or by refraining from heterosexual intercourse during the entire period of risk.

    E.4Principal exclusion criteria
    Exclusion criteria:
    1. Expected survival < 9 months
    2. Estimated glomerular filtration rate <25 ml/ min
    3. Karnofsky performance status <60%
    4. Diabetes mellitus treated with insulin or sulfonylureas
    5. Acute cardiac hospitalization or procedure within 4 weeks (HF hospitalization, myocardial infarction, pacemaker implantation, cardioversion, coronary angioplasty)
    6. Participation in other clinical trial not approved for co-enrollment
    7. Inability or unwillingness to comply with the study requirements
    8. Current SGLT2-inhibitor use or previous discontinuation due to side effects
    9. History of ketoacidosis
    10. Systolic blood pressure <90 mmHg
    11. Uncontrolled hypertension
    12. Severe hepatic impairment, unstable or rapidly progressing hepatic disease at the time of randomization as judged by the investigator.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is change in level or slope of NTproBNP during the treatment period compared to the non-treatment periods.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At every study visit
    E.5.2Secondary end point(s)
    • Change in Kansas City Cardiomyopathy Questionnaire total symptom score during the treatment period compared to the non-treatment period
    • Change in 6-minute walking distance during the treatment period compared to the non-treatment period
    • Safety endpoints:
    -Blood pressure
    -Diuretic intake
    -Any patient-reported side effect during treatment period with dapagliflozin .
    E.5.2.1Timepoint(s) of evaluation of this end point
    KCCQ - 3 times per period
    6 MWT - 3 times per period
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    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
    Last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    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: 2
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 8
    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 state10
    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)
    After study end there will be no additional intervention. Patients will receive standard of care according to national guidelines for Cardiac ATTR Amyloidosis.
    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 Decision2022-12-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-12-07
    P. End of Trial
    P.End of Trial StatusOngoing
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