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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2021-006639-24
    Sponsor's Protocol Code Number:2020/ABM/01/00080
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2022-04-07
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2021-006639-24
    A.3Full title of the trial
    Multicenter Polish Study of the Use of Bromocriptine in Perinatal Cardiomyopathy. New BioMarkers in the Early Diagnosis of Peripartum CardioMyopathy. PolBrom-PPCM
    Wieloośrodkowe Polskie Badanie Stosowania Bromokryptyny w Kardiomiopatii Okołoporodowej. Nowe BioMarkery we Wczesnej Diagnostyce Kardiomiopatii Okołoporodowej (PeriPartum CardioMyopathy). PolBroM-PPCM
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multicenter Polish Study of the Use of Bromocriptine in Perinatal Cardiomyopathy. New BioMarkers in the Early Diagnosis of Peripartum CardioMyopathy. PolBrom-PPCM
    Wieloośrodkowe Polskie Badanie Stosowania Bromokryptyny w Kardiomiopatii Okołoporodowej. Nowe BioMarkery we Wczesnej Diagnostyce Kardiomiopatii Okołoporodowej (PeriPartum CardioMyopathy). PolBroM-PPCM
    A.3.2Name or abbreviated title of the trial where available
    PolBroM-PPCM
    PolBroM-PPCM
    A.4.1Sponsor's protocol code number2020/ABM/01/00080
    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 SponsorThe Cardinal Stefan Wyszyński Institute of Cardiology
    B.1.3.4CountryPoland
    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 supportMedical Research Agency
    B.4.2CountryPoland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAneta Wielgosz
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressAlpejska 42
    B.5.3.2Town/ cityWarsaw
    B.5.3.3Post code04-628
    B.5.3.4CountryPoland
    B.5.4Telephone number+4822343 42 42
    B.5.6E-maila.wielgosz3@ikard.pl
    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 Bromocorn 2,5 mg
    D.2.1.1.2Name of the Marketing Authorisation holderFarmaceutyczna Spółdzielnia Pracy FILOFARM
    D.2.1.2Country which granted the Marketing AuthorisationPoland
    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 nameBromocorn 2,5 mg
    D.3.4Pharmaceutical form 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
    PeriPartum Cardiomiopathy
    Kardiomiopatia okołoporodowa
    E.1.1.1Medical condition in easily understood language
    heart muscle disease that occurs in the perinatal period
    choroba mięśnia sercowego występująca w okresie okołoporodowym
    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
    The project aims to assess the therapeutic effect of the new, intensified treatment regimen with bromocriptine at a dose of 2 x 2.5 mg for 14 days, then 1 x 2.5 mg for min. 42 days with an additional extension of therapy in NYHA class> I patients, no improvement in LVEF in TTE (LVEF <35% or no increase in LVEF by 10%) compared to the 7-day administration of bromocriptine at the minimum dose of 1 x 2.5 mg necessary to inhibit lactation.
    Projekt ma na celu ocenę efektu leczniczego nowego, zintensyfikowanego schematu leczenia bromokryptyną w dawce 2 x 2,5 mg przez 14 dni, następnie 1 x 2,5 mg przez min. 42 dni z dodatkowym wydłużeniem terapii u pacjentek w klasie NYHA >I, bez poprawy LVEF w TTE (LVEF < 35% lub brakiem wzrostu LVEF o 10%) w porównaniu do 7-dniowego stosowania bromokryptyny w dawce minimalnej 1 x 2,5 mg koniecznej do zahamowania laktacji.
    E.2.2Secondary objectives of the trial
    1. Creation of a new diagnostic scheme in PPCM, taking into account new biomarkers and biomarkers with already proven relationship with PPCM selected in the Project
    2. Development of a new reference key determination method in PPCM,
    3. A summary of the data on the severity of the fibrosis process, resulting from the concentration of the determined biomarkers, with the initial and six-month observation of the magnetic resonance image (including extended T1 and T2 times, ECV, LGE, GLS), as well as compared with selected echocardiographic parameters,
    4. Discovery of new mutations in genes for which the relationship with PPCM has not been shown so far.
    1. Stworzenie nowego schematu diagnostycznego w PPCM z uwzględnieniem wytypowanych w Projekcie nowych biomarkerów oraz biomarkerów o już udowodnionym związku z PPCM
    2. Opracowanie nowej referencyjnej metody oznaczenia kluczowego w PPCM,
    3. Zestawienie danych nasilenia procesu włóknienia, płynących ze stężenia oznaczanych biomarkerów, z wyjściowym i uzyskanym w sześciomiesięcznej obserwacji obrazem rezonansu magnetycznego (m.in. wydłużony czasy T1 i T2, ECV, LGE, GLS), jak również porównane z wybranymi parametrami echokardiograficznymi,
    4. Odkrycie nowych mutacji w genach, dla których dotychczas nie wykazano związku z PPCM.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Study group:
    - age ≥ 18 years of age
    - newly diagnosed heart failure, which occurred in the period from 24 weeks of pregnancy to 6 months after delivery
    - LVEF <45% in TTE with or without enlargement of left ventricular end diastolic dimensions (LVEDd)
    - no history of heart failure, heart disease or heart disease before pregnancy
    - no contraindications to bromocriptine treatment
    - expressing and signing informed consent to participate in the study
    Control group:
    - age ≥ 18 years of age
    - ≥24 weeks of pregnancy
    - no history of heart failure, heart disease or heart disease before pregnancy
    - correct LVEF ≥ 60% and LVEDd ≤56mm
    - expressing and signing informed consent to participate in the study
    Grupa badana:
    - wiek ≥ 18 r.ż.
    - nowo rozpoznana niewydolność serca, która wystąpiła w okresie od 24 tyg. ciąży do 6 miesięcy po porodzie
    - LVEF < 45% w badaniu TTE z lub bez powiększenia wymiary końcoworozkurczowugo lewej komory (LVEDd)
    - brak wywiadu niewydolności serca, chorób mięśnia serca lub chorób serca przed ciążą
    - brak przeciwwskazań do włączenia leczenia bromokryptyną
    - wyrażenie i podpisanie świadomej zgody na udział w badaniu
    Grupa kontrolna:
    - wiek ≥ 18 r.ż.
    - ≥24 tydzień ciąży
    - brak wywiadu niewydolności serca, chorób mięśnia serca lub chorób serca przed ciążą
    - prawidłowa LVEF ≥ 60% i LVEDd ≤56mm
    - wyrażenie i podpisanie świadomej zgody na udział w badaniu
    E.4Principal exclusion criteria
    Study group:

    - age <18 years old,
    - the appearance of symptoms of heart failure> 6 months after delivery,
    - normal left ventricular ejection fraction in echocardiography,
    - the presence of other causes of heart failure,
    heart disease found before pregnancy
    - diagnosed cardiomyopathy> 1 month prior to study enrollment,
    - contraindications to treatment with bromocriptine, which include i.a. uncontrolled hypertension, allergy to any component of the drug, symptoms of mental disorders or a history of severe mental disorders.
    - participation in another clinical trial with drug administration or use of a device prior to randomization
    - lack of informed consent to participate in the study.
    Control group:
    - age <18 years old,
    - heart disease diagnosed before or during pregnancy,
    - lack of informed consent to participate in the study
    Grupa badana:

    - wiek < 18 r.ż.,
    - pojawienie się objawów niewydolności serca > 6 miesięcy po porodzie,
    - prawidłowa frakcja wyrzucania lewej komory w badaniu echokardiograficznym,
    - obecność innych przyczyn niewydolności serca,
    - choroby serca stwierdzane przed zajściem w ciążę,
    - kardiomiopatia zdiagnozowana > 1 miesiąca przed włączeniem do badania,
    - przeciwwskazania do leczenia bromokryptyną, do których należą m.in. niekontrolowane nadciśnienie tętnicze, uczulenie na którykolwiek składnik leku, objawy zaburzeń psychicznych lub ciężkie zaburzenia psychiczne w wywiadzie.
    - udział w innym badaniu klinicznym z podaniem leku lub zastosowaniem urządzenia przed randomizacją
    - brak świadomej zgody na udział w badaniu.
    Grupa kontrolna:
    - wiek < 18 r.ż.,
    - choroba serca zdiagnozowana przed lub w trakcie ciąży,
    - brak świadomej zgody na udział w badaniu
    E.5 End points
    E.5.1Primary end point(s)
    The health effect endpoints against which the clinical effectiveness of prolonged bromocriptine treatment will be assessed compared to the 7-day treatment group include:
    - improvement in left ventricular ejection fraction (LVEF) ≥50%, increase in LVEF by 10 units (%) and delta of mean LVEF increase as assessed by transthoracic echocardiography and cardiac magnetic resonance imaging (CMRI) over a 6-month follow-up;
    - composite endpoint including hospitalizations for cardiovascular causes, mechanical support of the left ventricle, heart transplantation, sudden cardiac arrest including ventricular arrhythmias interrupted by the discharge of an implanted cardioverter-defibrillator, death from cardiovascular causes.
    Do punktów końcowych dotyczących efektu zdrowotnego, względem których będzie oceniana efektywność kliniczna przedłużonego leczenia bromokryptyną w porównaniu do grupy leczonej przez 7 dni, należą:
    - poprawa frakcji wyrzutowej lewej komory (LVEF) ≥50%, wzrost LVEF o 10 jednostek (%) oraz delta średniego wzrostu LVEF ocenianej w echokardiografii przezklatkowej i rezonansie magnetycznym serca (CMRI) w sześciomiesięcznej obserwacji;
    - złożony punkt końcowy zawierający hospitalizacje z przyczyn sercowo-naczyniowych, wszczepienie mechanicznego wspomagania lewej komory serca, przeszczep serca, nagłe zatrzymanie krążenia, w tym komorowe zaburzenia rytmu przerwane wyładowaniem wszczepionego kardiowertera-defibrylatora, zgon z przyczyn sercowo-naczyniowych.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Timing of the Primary Endpoint evaluation: final visit, end of study
    Momenty ewaluacji Pierwszorzędowego Punktu Końcowego: wizyta końcowa, zakończenie badania
    E.5.2Secondary end point(s)
    - days alive out of hospitalization;
    - the appearance of ventricular arrhythmia or atrial fibrillation;
    - improvement of cardiovascular capacity by at least one NYHA class;
    - improvement in the quality of life assessed using the abbreviated version of the World Health Organization (WHO) quality of life survey WHOQOL-BREF
    - dni przeżyte bez hospitalizacji (day alive out of hospitalization);
    - pojawienie się arytmii komorowej lub migotania przedsionków;
    - poprawa wydolności krążenia co najmniej o jedną klasę wg NYHA;
    - poprawa jakości życia oceniona za pomocą skróconej wersji ankiety Światowej Organizacji Zdrowia (WHO) oceniającej jakość życia WHOQOL-BREF
    E.5.2.1Timepoint(s) of evaluation of this end point
    - isolation of a biomarker or a set of biomarkers (from among the 16 kDa PRL, sFlt1, PlGF, PAI-1, 30 miR panel, including miR146a, Gal-3, PINP, PIIINP, MPO, MMP-1, TIMP-1), which will be the optimal indicator of the presence of PPCM - based on the concentration of biomarkers in the group of patients with PPCM at the time of diagnosis compared with their concentrations in the control group in a given time interval of pregnancy / puerperium (Table 1.2);
    - separation of a biomarker which is the optimal indicator of response to bromocriptine therapy or persistence of severe heart failure in patients with PPCM over a 6-month follow-up;
    - discovery of new mutations related to the occurrence of PPCM
    - wyodrębnienie biomarkera lub zestawu biomarkerów (z pośród 16 kDa PRL, sFlt1, PlGF, PAI-1, panelu 30 miR, w tym miR146a, Gal-3, PINP, PIIINP, MPO, MMP-1, TIMP-1), który będzie optymalnym wskaźnikiem występowania PPCM - na podstawie stężeń biomarkerów w grupie pacjentek z PPCM w momencie rozpoznania w porównaniu z ich stężeniamim w grupie kontrolnej w danym przedziale czasowym ciąży/połogu (Tabela 1,2);
    - wyodrębnienie biomarkera, który optymalnym wskaźnikiem odpowiedzi na leczenie bromokryptyną lub utrzymywania się ciężkiej niewydolności serca u pacjentek z PPCM w obserwacji 6-cio miesięcznej;
    - odkrycie nowych mutacji mających związek z występowaniem PPCM
    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) 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 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
    bromokryptyna 2,5mg
    Bromocorn 2,5mg
    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 concerned7
    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
    LVLS
    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 months7
    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: 128
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 No
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation Yes
    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 state128
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 128
    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 Decision2022-10-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-01-10
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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