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    Summary
    EudraCT Number:2013-001067-23
    Sponsor's Protocol Code Number:i-PHORECAST
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-11-18
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2013-001067-23
    A.3Full title of the trial
    PHOspholamban RElated CArdiomyopathy STudy - intervention (i-PHORECAST)
    Fosfolamban gerelateerde cardiomyopathie studie - interventie (i-PHORECAST)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phospolamban heart muscle disorder
    Fosfolamban erfelijke hartspierziekte
    A.3.2Name or abbreviated title of the trial where available
    i-PHORECAST
    i-PHORECAST
    A.4.1Sponsor's protocol code numberi-PHORECAST
    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 SponsorUniversity Medical Centre Groningen
    B.1.3.4CountryNetherlands
    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 supportZonMw: The Netherlands Organisation for Health Research and Development
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportNetherlands: CVON, CardioVascular Research Netherlands
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Centre Groningen
    B.5.2Functional name of contact pointW.p. te Rijdt
    B.5.3 Address:
    B.5.3.1Street AddressHanzeplein 1
    B.5.3.2Town/ cityGroningen
    B.5.3.3Post code9713 GZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number00310503615385
    B.5.6E-mailw.p.te.rijdt@umcg.nl
    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 Inspra (Eplerenone), Pfizer Inc.
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratórios Pfizer, Lda., Porto Salvo, Portuga
    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 nameEplerenone (Inspra, Pfizer Inc.)
    D.3.2Product code 0025-1710
    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
    Phospholamban-related
    Cardiomyopathy
    Fosfolamban-gerelateerde
    Cardiomyopathie
    E.1.1.1Medical condition in easily understood language
    Phospholamban-related heart muscle disorder
    Fosfolamban-gerelateerde hartspierziekte
    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 10061029
    E.1.2Term Cardiomyopathy primary
    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
    The primary objective is to show that eplerenone treatment reduces progression of disease in presymptomatic PLN R14del-carriers
    Het primaire doel is om aan te tonen dat eplerenone behandeling de progressie van de ziekte vertraagd in presymtpmatische PLN R14del dragers
    E.2.2Secondary objectives of the trial
    -To investigate whether biomarkers predict disease progression
    -To investigate whether treatment with eplerenone affects:
    Diagnosis of DCM
    Diagnosis of ARVC (according to task force criteria)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    PLN R14del mutation carriers
    Age ≥30 and ≤ 65 years
    New York Heart Association functional class ≤ 1
    LV ejection fraction ≥.45 (measured with MRI)
    PLN R14del mutatie dragers
    Leeftijd ≥30 en ≤ 65 jaar
    New York Heart Association functionele klasse ≤ 1
    LV ejectie fractie ≥.45 (gemeten met MRI)
    E.4Principal exclusion criteria
    •Palpitations necessitating treatment (at the discretion of the attending physician)
    •A diagnosis of DCM (see appendix 1). Note: regional LV wall motions abnormalities are acceptable.
    •A diagnosis of ARVC (according to the task force criteria)
    •Global or regional RV dysfunction and/or structural alterations (according to
    task force criterion 1).
    •Ventricular premature complexes >1000 during 24hours Holter-monitoring
    •Non-sustained ventricular tachycardia during Holter-monitoring or exercise-testing
    •History of sustained ventricular tachycardia or ventricular fibrillation
    •Hypertension requiring the use of antihypertensive drugs, or when this is
    anticipated within the coming 3 years
    •Evidence of ischemic heart disease
    •Treatment with cardioactive medication
    •Hyperkaliemia (serum potassium >5.0 mmol/l)
    •Severe renal dysfunction (eGFR <30 ml/min/1.73 m2)
    •Severe hepatic impairment (Child-Pugh class C)
    •Women who are currently pregnant or report a recent pregnancy (last 60 days) or plan on becoming pregnant.
    •Concomitant use of CYP3A4-inhibitors
    •Concomitant use of NSAIDs
    •Concomitant use of potassium highering/sparing-agents
    •Known intolerance or contraindication to aldosterone antagonists
    •Participation in another drug trial in which the last dose of drug was within the past 30 days.
    •Contra-indications for MRI (claustrophobia, metal devices)
    •Subjects unable or unwilling to provide written informed consent
    Note: presence of late gadolinium enhancement on MRI is not an exclusion criterion
    •Palpitaties waarbij behandeling geindiceerd is (ter beoordeling door behandelend arts)
    •Diagnose van DCM. NB: regionale LV wandbewegingstoornissen zijn acceptabel.
    •Diagnose van ARVC (volgens de task force criteria)
    •Globale of regionale RV dysfunctie en/of structurele veranderingen (volgens de
    task force criterion 1).
    •Ventriculaire premature complexen >1000 tijdens 24uurs Holter-monitoring
    •Non-sustained ventriculaire tachycardie tijdens Holter-monitoring of inspannings-test
    •Voorgeschiedenis van sustained ventriculaire tachycardie of ventriculaire fibrillatie
    •Hypertensie waarbij nood aan antihypertensieve medicatie, of wanneer dit verwacht wordt de komende 3 jaar
    •Bewijs van ischemische hart ziekte
    •Behandeling met cardioactieve medicatie
    •Hyperkaliemie (serum kalium >5.0 mmol/l)
    •Ernstige nierfunctiestoornissen (eGFR <30 ml/min/1.73 m2)
    •Ernstige leverfunctiestoornissen (Child-Pugh klasse C)
    •Vrouwen die momenteel zwanger zijn of een recente zwangerschap vermelden (laatste 60 dagen) of plannen om zwanger te worden
    •Gebruik van CYP3A4-inhibitoren tegelijkertijd (b.v. itroconazol, ketoconazol, nelfinavir, claritromycin)
    •NSAIDs gebruik tegelijkertijd
    •Gebruik van kalium-verhogende medicatie
    •Bekende intolerantie of contraindicatie voor aldosterone antagonisten
    •Deelname aan andere medicatie of device trial waarin de laatste dosis van het medicament tijdens de laatste 30 dagen plaatsvond
    •Proefpersonen zonder mogelijkheid of onwillend geschreven informed consent te geven
    NB: Aanwezigheid van late gadolinium aankleuring op MRI is niet een exclusie criterium
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is a composite of at least one the following components:
    •LV enddiastolic volume, increase >10%
    •LV ejection fraction, absolute decrease >5%
    •RV enddiastolic volume, increase >10%
    •RV ejection fraction, absolute decrease >5%
    •late enhancement, absolute increase >5%
    (all the above parameters to be assessed with MRI)
    •QRS voltage, decrease >25% (ECG)
    •ventricular premature complexes, increase >100% in combination with absolute number >1000/24 hrs (Holter monitoring)
    •the occurrence of non-sustained ventricular tachycardia (Holter monitoring, exercise testing)
    •symptoms/signs of heart failure and/or arrhythmias necessitating treatment according to the attending physician and likely due to arrhythmogenic cardiomyopathy
    •cardiovascular death, including sudden death, likely due to arrhythmogenic cardiomyopathy
    Het primaire eindpunt is een verzameling van tenminste een van de volgende componenten:
    •LV einddiastolisch volume, stijging >10%
    •LV ejectie fractie, absolute daling >5%
    •RV einddiastolisch volume, stijging >10%
    •RV ejectie fractie, absolute daling >5%
    •late aankleuing, absolute stijging >5%
    (al de bovengenoemde parameters worden beoordeeld door MRI)
    •QRS voltage, daling >25% (ECG)
    •ventriculaire premature complexen, stijging >100% in combinatie met absolute nummer >1000/24 uur (Holter monitoring)
    •het optreden van non-sustained ventriculaire tachycardie (Holter monitoring, inspanningstest)
    •symptomen/tekenen van hartfalen en/of aritmien waardoor behandeling nodig volgens inschatting van de behandelende arts en waarschijnlijke onderliggende oorzaak aritmogene cardiomyopathie
    •cardiovasculaire dood, inclusief plotse hartdood, waarschijnlijk door aritmogene cardiomyopathie
    E.5.1.1Timepoint(s) of evaluation of this end point
    At baseline and after 3 years of follow-up MRI-endpoints and SA-ECG will be assessed.
    Subjects visit the outpatient clinic at baseline and at one year-intervals (at 0, 1, 2 and 3 years) thereafter, including electrocardiographic, Echocardiographic
    Holter and ergometry evaluation.
    E.5.2Secondary end point(s)
    •Diagnosis of DCM (see appendix 1)
    •Diagnosis of ARVC (according to task force criteria, see appendix 2)
    •Development of global or regional dysfunction and structural alterations,
    (according to task force criterion 1, see appendix 2)
    •All individual components of the primary endpoint
    •QRS-axis on 12-lead ECG
    •Conduction intervals (PR-interval, QRS-duration) on 12-lead ECG and SA-ECG
    •STT-segment changes on 12-lead ECG
    •Change in biomarkers
    •Occurrence of sustained ventricular tachycardia or ventricular fibrillation
    •Hospitalization for a cardiovascular reason
    •Diagnose van DCM
    •Diagnose van ARVC (volgens de task force criteria)
    •Ontwikkelen van globale of regionale dysfunctie en structurele veranderingen
    (volgens de task force criteria)
    •Alle individuele componenten van het primaire eindpunt
    •QRS-as op 12-lead ECG
    •Conductie intervallen (PR-interval, QRS-duur) op 12-lead ECG en SA-ECG
    •STT-segment veranderingen op 12-lead ECG
    •Veranderingen in biomarkers
    •Optreden van sustained ventriculaire tachycardie of ventriculaire fibrillatie
    •Hospitalisatie voor een cardiovasculaire reden
    E.5.2.1Timepoint(s) of evaluation of this end point
    At baseline and after 3 years of follow-up MRI-endpoints and SA-ECG will be assessed.
    Subjects visit the outpatient clinic at baseline and at one year-intervals (at 0, 1, 2 and 3 years) thereafter, including electrocardiographic, Echocardiographic, Holter and ergometry evaluation.
    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) 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 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 Yes
    E.8.2.3.1Comparator description
    no treatment/intervention
    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 concerned4
    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
    The end of the study is defined as the last patient’s last visit.
    The study will be terminated prematurely in case the DSMB has serious concerns about the safety of the treatment.
    In case the study is ended prematurely, the sponsor will notify the accredited METC and the competent authority within 15 days, including the reasons for the premature termination.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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: 150
    F.1.3Elderly (>=65 years) No
    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 state150
    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)
    In addition to standard evidence-based medical treatment, if our hypothesis is confirmed that eplerenone retards disease progression in this patient group, treatment with eplerenone can be instituted right away in all study subjects (as well as other presymptomatic PLN R14del-mutation carriers)
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation ICIN
    G.4.3.4Network Country Netherlands
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-11-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-02-10
    P. End of Trial
    P.End of Trial StatusOngoing
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