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Authors
Steichert, Melina https://orcid.org/0009-0006-1522-5458
Cawello, Willi
Laeer, Stephanie
,
Breitkreutz, Jörg
Klingmann, Ingrid
Lagler, Florian
de Hoon, Jan
Dalinghaus, Michiel
Bajcetic, Milica
de Wildt, Saskia N.
Keatley-Clarke, Anne
Breur, Johannes M. P. J.
Male, Christoph
Ablonczy, Laszlo
Mir, Thomas
Vukomanovic, Vladislav
Dukic, Milan
Jovanovic, Ida
Burckhardt, Bjoern B.
Kleine, Karl
Moder, Angelika
Obarcanin, Emina
Wagner, Peter
Walsh, Jennifer
van Hecken, Anne
Spatenkova, Lucie
Ali, Mohsin
Božić, Bojana
Bijelić, Maja
Burdman, Ilja
Ciplea, Agnes
Faisal, Muhammed
Farahani, Samieh
Feickert, Martin
Gangnus, Tanja
Lazic, Milica
Makowski, Nina
Süssenbach, Fabian
van der Meulen, Marijke
Popović, Saša
Parezanović, Miro
Smeets, Nori
Swoboda, Vanessa
Bojanin, Dragana
Đorđević, Stefan
Dragić, Jasminka
Holle, Ann-Kathrin
Jovičić, Bosiljka
Košutić, Jovan
Kozomara, Gordana
Majid, Haidara
Mitrović, Jadranka
Ninić, Sanja
Parezanovic, Miro
Parezanovic, Vojislav
Pavlović, Andrija
Prijić, Sergej
Rebić, Branislava
Stefanović, Igor
Tordas, Daniel
Vulićević, Irena
Bartel, Anke
Čeko, Andjelka
Herborts, Marissa
Hennink, Annelies
Kosanović, Bosiljka
Kostic, Sanja
Isailović, Ljiljana
Maksimovic, Jasmina
Manai, Badies
Martinović, Nada
Máté, Gyöngyi
Perišić, Miloš
Reljić, Jelena
Pirker, Regina
Salamomovic, Marta
Schlesner, Claudia
Tins, Jutta
Wissmann, Eva
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Funding
Funding for this research was provided by:
Seventh Framework Programme (602295)
Heinrich-Heine-Universität Düsseldorf
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Article History
Accepted: 22 April 2025
First Online: 3 June 2025
Declarations
:
: Open Access funding enabled and organized by Projekt DEAL. The research work is based on the data of the project Labeling of Enalapril from Neonates up to Adolescents (LENA), which was funded by a European Union Seventh Framework Program (FP7/2007-2013) under the grant agreement no. 602295. The open access fee was funded by the Heinrich Heine University Düsseldorf.
: The authors declare no conflicts of interest.
: The analysed datasets from the LENA project are not publicly available due to the data protection contract of the product owner.
: The study protocols responding to specific national requirements were submitted to the responsible Independent Ethics Committees (IECs) in the participating countries for review and received approval. The address from the Ethics Committee of the coordinating principal investigator’s IEC of Study EudraCT 2015-002335-17 (DCM patients) was: Secretariaat Medisch Ethische Toetsings Commissie Erasmus MC, Postbus 2040, 3000 CA Rotterdam, the Netherlands, NL, dossiers: 4 December 2015, nos. NL54914.078.15, NL54738.078.15, MEC-2015-634 and MEC-2015-635; Ethics Committee UMC Utrecht, NL: 17 February 2016 nos. Mvd/vb/16/004864, Mvd/vb/16/004964; Medical Research Council, Ethics Committee for Clinical Pharmacology, National Institute of Pharmacy and Nutrition, Budapest, 30 November 2015, nos. OGYI/36681-7/2015 and OGYI/36999-9/2015; Ethikkommission Medizinische Universität Wien: 21 December 2015 no.1803/2015. The address of the coordinating principal investigator’s IEC of study EudraCT 2015-002396-18 (CHD patients) was: Ethics Committee of the University Children’s Hospital in Belgrade and the Institute of Mother and Child Health ‘Dr Vukan Čupić’ Univerzitetska Dečja Klinika, Tirsova 10, 11129 Belgrade, Serbia. 29 February 2016 and 5 April 2017, nos. 26/307 and 8/9; Ethikkommisison der Ärztekammer Hamburg, Germany, 22 May 2017, PVN9495 and PVN5496. The studies were conducted in accordance with the Declaration of Helsinki.
: Informed parental consent was obtained for each subject included in the studies. Assent of participating children was obtained in accordance with national requirements.
: Not applicable.
: Not applicable.
: Conception and design of the work were developed by M.S., C.W. and S.L. Data preparation was performed by M.S. M.S. performed the population pharmacokinetic analysis and simulations. W.C. and S.L. critically reviewed and discussed the analysis and simulations. M.S. drafted the manuscript. W.C. and S.L. critically reviewed and revised the manuscript. All authors read and approved the final manuscript.
