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    Summary
    EudraCT Number:2013-005054-30
    Sponsor's Protocol Code Number:CamiciSerelaxin2013_CRLX030AIT01T
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-03-14
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2013-005054-30
    A.3Full title of the trial
    A mechanistic study to evaluate the effect of Serelaxin on left ventricular function and its correlation with outcome in acute heart failure
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study aiming at evaluating the affect of a new drug serelaxin on the capacity of work of the left chamber of the heart and its impact on the outcome in patients with acute heart failure.
    A.4.1Sponsor's protocol code numberCamiciSerelaxin2013_CRLX030AIT01T
    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 SponsorOspedale San Raffaele s.r.l.
    B.1.3.4CountryItaly
    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 supportOspedale San Raffaele Srl
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOspedale San Raffaele Srl
    B.5.2Functional name of contact pointUfficio Ricerche Cliniche
    B.5.3 Address:
    B.5.3.1Street AddressVia Olgettina 60
    B.5.3.2Town/ cityMilano
    B.5.3.4CountryItaly
    B.5.4Telephone number00390326433531
    B.5.6E-mailriva.elisabetta@hsr.it
    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 nameSerelaxin
    D.3.2Product code RLX030
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSERELAXIN
    D.3.9.1CAS number 99489-94-8
    D.3.9.3Other descriptive nameRLX030
    D.3.9.4EV Substance CodeSUB119779
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    Acute Heart Failure
    E.1.1.1Medical condition in easily understood language
    Acute shortness of breath due to heart failure
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10000803
    E.1.2Term Acute heart failure
    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
    Demonstration of a significant reduction in indexed left ventricular end systolic volume (LVESVi) assessed by cardiac magnetic resonance (CMR) in the serelaxin group compared to controls at 6 months follow up.
    E.2.2Secondary objectives of the trial
    Changes in LVESVi, assessed by echo, between baseline and 6 month in the serelaxin group compared to controls.
    - Correlation between changes in echocardiographic parameters of cardiac function and cardiac, renal and hepatic biomarkers.
    - Changes in late gadolinium enhancement at CMR in the two groups between baseline and 6 months.
    - Comparison of the NYHA functional class at 6 months between the Serelaxin group and controls.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Dyspnea at rest or with minimal exertion
    Pulmonary congestion on chest radiograph
    Able to start serelaxin infusion within 16 hours from presentation to the hospital
    Received IV furosemide of at least 40 mg (or equivalent) at any time between admission to emergency services (either ambulance or hospital, including the ED) and the start of screening for the study.
    Impaired renal function defined as an estimated glomerular filtration rate (eGFR) on admission between 30-75 mL/min/1•73 m2, calculated using the simplified Modification of Diet in Renal Disease (sMDRD) equation.
    E.4Principal exclusion criteria
    Dyspnoea primarily due to non-cardiac causes
    Women of child bearing potential or pregnant or nursing (lactating) women
    Temperature >38.5°C (oral or equivalent) or sepsis or active infection requiring IV anti-microbial treatment
    Current (within 2 hours prior to screening) or planned treatment with any IV vasoactive therapies, including vasodilators, positive inotropic agents and vasopressors, or mechanical support, with the exception of IV furosemide (or equivalent) or IV nitrates ≤ 0.1mg/kg if the patient has a systolic BP >150 mmHg at screening
    Significant left ventricular outflow obstruction, such as obstructive hypertrophic cardiomyopathy or severe aortic stenosis (i.e., aortic valve area <1.0 cm2 or mean gradient >50 mmHg on prior or current echocardiogram) and severe mitral stenosis
    Known hepatic impairment, or AST or ALT >3 times Upper Limit of Normal of unknown source
    Known presence of active or recurrent bacterial, fungal or viral infection at the time of enrollment, e.g. evidence of Human Immunodeficiency Virus (HIV) infection, Hepatitis B and Hepatitis C infections (based on history and/or clinical findings, including laboratory results obtained during screening period, known significant pulmonary disease.
    Shock regardless of aetiology
    AHF caused by significant arrhythmias, acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy
    Clinical evidence of Acute Coronary Syndrome currently or diagnosed within 30 days prior to enrolment. (Note that the diagnosis of acute coronary syndrome is a clinical diagnosis and that the sole presence of elevated troponin concentrations is not sufficient for a diagnosis of acute coronary syndrome, given that troponin concentrations may be significantly increased in the setting of AHF)
    Troponin ≥3 times the level indicative of myocardial infarction
    Known hypersensitivity to Serelaxin or similar substances or to any of the excipients
    Pacemaker or ICD.
    Implanted ferromagnetic cerebrovascular clips.
    Claustrophobia.
    Involved in other research studies

    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study is the demonstration of a significant reduction in indexed left ventricular end systolic volume (LVESVi) assessed by cardiac magnetic resonance (CMR) in the serelaxin group compared to controls at 6 months follow up.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months
    E.5.2Secondary end point(s)
    - Changes in LVESVi, assessed by echo, between baseline and 6 month in the serelaxin group compared to controls.
    - Correlation between changes in echocardiographic parameters of cardiac function assessed at screening (visit 0), 24 hour, 48 hours, day 4 and at 1, 2, 6 months and cardiac, renal and hepatic biomarkers assessed at baseline, 24 hour, 48 hours, day 4 and at 6 months.
    - Changes in late gadolinium enhancement at CMR in the two groups between baseline and 6 months.
    - Comparison of the NYHA functional class at 6 month between the Serelaxin group and controls.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline, 24 hour, 48 hours, day 4 and at 6 months
    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 Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Standard optimal medical therapy
    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 concerned2
    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 years2
    E.8.9.1In the Member State concerned months
    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: 18
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 18
    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 No
    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 state36
    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 return to standard therapy care of general practitioner
    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 Decision2014-06-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-02-06
    P. End of Trial
    P.End of Trial StatusOngoing
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