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15 results on '"Ablonczy, László"'

1. Orodispersible minitablets of enalapril for use in children with heart failure (LENA): Rationale and protocol for a multicentre pharmacokinetic bridging study and follow-up safety study

Author

Bajcetic, Milica, de Wildt, Saskia N., Dalinghaus, Michiel, Breitkreutz, Jörg, Klingmann, Ingrid, Lagler, Florian B., Keatley-Clarke, Anne, Breur, Johannes MPJ., Male, Christoph, Jovanovic, Ida, Szatmári, Andras, Ablonczy, László, Burckhardt, Bjoern B., Cawello, Willi, Kleine, Karl, Obarcanin, Emina, Spatenkova, Lucie, Swoboda, Vanessa, van der Meulen, Marijke, Wagner, Peter, Walsh, Jennifer, and Läer, Stephanie

Published
2019
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3. Edoxaban for Thromboembolism Prevention in Pediatric Patients With Cardiac Disease

Author

Portman, Michael A., primary, Jacobs, Jeffrey P., additional, Newburger, Jane W., additional, Berger, Felix, additional, Grosso, Michael A., additional, Duggal, Anil, additional, Tao, Ben, additional, Goldenberg, Neil A., additional, Brothers, Matthew, additional, Marino, Bradley, additional, Canter, Charles, additional, Law, Mark, additional, Nguyen, Nguyenvu, additional, Sang, Charlie, additional, Shimano, Kristin, additional, Gupta, Dipankar, additional, Portman, Michael, additional, Williams, Derek, additional, Glass, Lauren, additional, Sperrazza, Charles, additional, Herold, Steven, additional, Garg, Ruchira, additional, Vranicar, Mark, additional, Awad, Sawsan, additional, Asante-Korang, Alfred, additional, Druzgal, Colleen, additional, Ozment, Caroline, additional, Del Toro, Kamill, additional, Roses, Ferran, additional, Jux, Christian, additional, Gravenhorst, Verena, additional, Schweigmann, Ulrich, additional, Bhatt, Mihir, additional, Sabapathy, Christine, additional, Dahdah, Nagib, additional, Bartonicek, Dototea, additional, Tulzer, Gerald, additional, Basargina, Elena, additional, Zvereva, Tatiana, additional, Pertels, Tatiana, additional, Plotnikova, Irina, additional, Pierre-Emmanuel, S.E.G.U.E.L.A., additional, Amedro, Pascal, additional, Yves, Dulac, additional, BONNET, Damien, additional, Saraco, Paola, additional, Rimini, Alessandro, additional, Digtiar, Valerii, additional, Gonchar, Margaryta, additional, Kryuchko, Tetyana, additional, Yablon, Olga, additional, Bedi, Varinder Singh, additional, Patel, Jashvant, additional, Mitra, Monjori, additional, Kusa, Jacek, additional, Domagala, Kowalczyk, additional, KÖRNYEI, László, additional, BERECZKI, Csaba, additional, ABLONCZY, László, additional, Levitas, Vivianne Aviva, additional, Mishali, David, additional, Revel-Vilk, Shoshana, additional, Harlev, Dan, additional, Sasmaz, Hatice Ilgen, additional, Ozbek, Namik Yasar, additional, Unal, Sule, additional, Patıroglu, Türkan, additional, Malbora, Baris, additional, Agin, Hasan, additional, Karakas, Zeynep, additional, Kavakli, Ramazan Kaan, additional, Chalmers, Elizabeth, additional, Bu'Lock, Frances, additional, Daubeney, Piers, additional, Hamza, Hala, additional, Badr, Mohamed, additional, Elalfy, Mohsen, additional, Mansour, Ahmed, additional, Hassab, Hoda, additional, Sabry, Ayman, additional, Daou, Linda, additional, and Bitar, Fadi, additional

Published
2022
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4. Enalapril and Enalaprilat Pharmacokinetics in Children with Heart Failure Due to Dilated Cardiomyopathy and Congestive Heart Failure after Administration of an Orodispersible Enalapril Minitablet (LENA-Studies)

Author

Laeer, Stephanie, primary, Cawello, Willi, additional, Burckhardt, Bjoern B., additional, Ablonczy, László, additional, Bajcetic, Milica, additional, Breur, Johannes M. P. J., additional, Dalinghaus, Michiel, additional, Male, Christoph, additional, de Wildt, Saskia N., additional, Breitkreutz, Jörg, additional, Faisal, Muhammed, additional, Keatley-Clarke, Anne, additional, Klingmann, Ingrid, additional, and Lagler, Florian B., additional

Published
2022
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5. Enalapril and Enalaprilat Pharmacokinetics in Children with Heart Failure Due to Dilated Cardiomyopathy and Congestive Heart Failure after Administration of an Orodispersible Enalapril Minitablet (LENA-Studies)

Author

Laeer, Stephanie, Cawello, Willi, Burckhardt, Bjoern B., Ablonczy, László, Bajcetic, Milica, Breur, Johannes M.P.J., Dalinghaus, Michiel, Male, Christoph, de Wildt, Saskia N., Breitkreutz, Jörg, Faisal, Muhammed, Keatley-Clarke, Anne, Klingmann, Ingrid, Lagler, Florian B., Laeer, Stephanie, Cawello, Willi, Burckhardt, Bjoern B., Ablonczy, László, Bajcetic, Milica, Breur, Johannes M.P.J., Dalinghaus, Michiel, Male, Christoph, de Wildt, Saskia N., Breitkreutz, Jörg, Faisal, Muhammed, Keatley-Clarke, Anne, Klingmann, Ingrid, and Lagler, Florian B.

Abstract

Angiotensin-converting enzyme inhibitors (ACEI), such as enalapril, are a cornerstone of treatment for pediatric heart failure which is still used off-label. Using a novel age-appropriate formulation of enalapril orodispersible minitablets (ODMTs), phase II/III open-label, multicenter pharmacokinetic (PK) bridging studies were performed in pediatric patients with heart failure due to dilated cardiomyopathy (DCM) and congenital heart disease (CHD) in five participating European countries. Children were treated for 8 weeks with ODMTs according to an age-appropriate dosing schedule. The primary objective was to describe PK parameters (area under the curve (AUC), maximal concentration (Cmax), time to reach maximal concentration (t-max)) of enalapril and its active metabolite enalaprilat. Of 102 patients, 89 patients (n = 26, DCM; n = 63 CHD) were included in the primary PK endpoint analysis. Rate and extent of enalapril and its active metabolite enalaprilat were described and etiology and age could be identified as potential PK modifying factors. The dosing schedule appeared to be tolerated well and did not result in any significant drug-related serious adverse events. The PK analysis and the lack of severe safety events supports the applied age-appropriate dosing schedule for the enalapril ODMTs.

Published
2022

6. Enalapril and Enalaprilat Pharmacokinetics in Children with Heart Failure Due to Dilated Cardiomyopathy and Congestive Heart Failure after Administration of an Orodispersible Enalapril Minitablet (LENA-Studies)

Author

Cardiologie onderzoek 1, Child Health, Circulatory Health, Regenerative Medicine and Stem Cells, Laeer, Stephanie, Cawello, Willi, Burckhardt, Bjoern B, Ablonczy, László, Bajcetic, Milica, Breur, Johannes M P J, Dalinghaus, Michiel, Male, Christoph, de Wildt, Saskia N, Breitkreutz, Jörg, Faisal, Muhammed, Keatley-Clarke, Anne, Klingmann, Ingrid, Lagler, Florian B, Cardiologie onderzoek 1, Child Health, Circulatory Health, Regenerative Medicine and Stem Cells, Laeer, Stephanie, Cawello, Willi, Burckhardt, Bjoern B, Ablonczy, László, Bajcetic, Milica, Breur, Johannes M P J, Dalinghaus, Michiel, Male, Christoph, de Wildt, Saskia N, Breitkreutz, Jörg, Faisal, Muhammed, Keatley-Clarke, Anne, Klingmann, Ingrid, and Lagler, Florian B

Published
2022

7. Study design and rationale of the pAtients pResenTing with cOngenital heaRt dIseAse Register (ARTORIA‐R)

Author

Sinning, Christoph, Zengin, Elvin, Diller, Gerhard-Paul, Onorati, Francesco, Castel, María-Angeles, Petit, Thibault, Chen, Yih-Sharng, Lo Rito, Mauro, Chiarello, Carmelina, Guillemain, Romain, Coniat, Karine Nubret-Le, Magnussen, Christina, Knappe, Dorit, Becher, Peter Moritz, Schrage, Benedikt, Smits, Jacqueline M., Metzner, Andreas, Knosalla, Christoph, Schoenrath, Felix, Miera, Oliver, Cho, Mi-Young, Bernhardt, Alexander, Weimann, Jessica, Goßling, Alina, Terzi, Amedeo, Amodeo, Antonio, Alfieri, Sara, Angeli, Emanuela, Ragni, Luca, Napoleone, Carlo Pace, Gerosa, Gino, Pradegan, Nicola, Rodrigus, Inez, Dumfarth, Julia, de Pauw, Michel, François, Katrien, Van Caenegem, Olivier, Ancion, Arnaut, Van Cleemput, Johan, Miličić, Davor, Moza, Ajay, Schenker, Peter, Thul, Josef, Steinmetz, Michael, Warnecke, Gregor, Ius, Fabio, Freyt, Susanne, Avsar, Murat, Sandhaus, Tim, Haneya, Assad, Eifert, Sandra, Saeed, Diyar, Borger, Michael, Welp, Henryk, Ablonczy, László, Schmack, Bastian, Ruhparwar, Arjang, Naito, Shiho, Hua, Xiaoqin, Fluschnik, Nina, Nies, Moritz, Keil, Laura, Senftinger, Juliana, Ismaili, Djemail, Kany, Shinwan, Csengeri, Dora, Cardillo, Massimo, Oliveti, Alessandra, Faggian, Giuseppe, Dorent, Richard, Jasseron, Carine, Blanco, Alicia Pérez, Márquez, José Manuel Sobrino, López-Vilella, Raquel, García-Álvarez, Ana, López, María Luz Polo, Rocafort, Alvaro Gonzalez, Fernández, Óscar González, Prieto-Arevalo, Raquel, Zatarain-Nicolás, Eduardo, Blanchart, Katrien, Boignard, Aude, Battistella, Pascal, Guendouz, Soulef, Houyel, Lucile, Para, Marylou, Flecher, Erwan, Gay, Arnaud, Épailly, Éric, Dambrin, Camille, Lam, Kaitlyn, Ka-lai, Cally Ho, Cho, Yang Hyun, Choi, Jin-Oh, Kim, Jae-Joong, Coats, Louise, Crossland, David Steven, Mumford, Lisa, Hakmi, Samer, Sivathasan, Cumaraswamy, Fabritz, Larissa, Schubert, Stephan, Gummert, Jan, Hübler, Michael, Jacksch, Peter, Zuckermann, Andreas, Laufer, Günther, Baumgartner, Helmut, Giamberti, Alessandro, Reichenspurner, Hermann, and Kirchhof, Paulus

Subjects
Heart Defects, Congenital, Adult, Cardiac & Cardiovascular Systems, Heart Defects, Congenital / therapy, Waiting Lists, Study Designs, Medizin, Heart transplantation, Heart Defects, Congenital / complications, MANAGEMENT, Diseases of the circulatory (Cardiovascular) system, Humans, ESC GUIDELINES, Heart Failure / therapy, Adults with congenital heart disease, Arrhythmia, Heart failure, Heart transplantation, Lung transplantation, Ventricular assist device, Retrospective Studies, GENERAL-POPULATION, Heart Failure, OUTCOMES, Study Design, Science & Technology, TRANSPLANTATION, MORTALITY, Heart Failure / epidemiology, Heart Transplantation / adverse effects, ADULTS, ASSOCIATION, EUROPEAN-SOCIETY, Lung transplantation, Heart Failure / etiology, RC666-701, Cardiovascular System & Cardiology, Ventricular assist device, Heart Transplantation, Heart Defects, Congenital / epidemiology, Adults with congenital heart disease, Human medicine, Life Sciences & Biomedicine, Arrhythmia, TASK-FORCE
Abstract

ESC heart failure 8(6), 5542-5550 (2021). doi:10.1002/ehf2.13574, Published by Wiley, Chichester

Published
2021
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8. Simulation Training to Improve Informed Consent and Pharmacokinetic/Pharmacodynamic Sampling in Pediatric Trials

Author

Burckhardt, Bjoern B., primary, Ciplea, Agnes Maria, additional, Laven, Anna, additional, Ablonczy, László, additional, Klingmann, Ingrid, additional, Läer, Stephanie, additional, Kleine, Karl, additional, Dalinghaus, Michiel, additional, Đukić, Milan, additional, Breur, Johannes M. P. J., additional, van der Meulen, Marijke, additional, Swoboda, Vanessa, additional, Schwender, Holger, additional, and Lagler, Florian B., additional

Published
2020
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9. Clinical characteristics and outcomes of patients with adult congenital heart disease listed for heart and heart‒lung transplantation in the Eurotransplant region.

Author

UCL - SSS/IREC/MEDA - Pôle de médecine aiguë, UCL - (SLuc) Service de soins intensifs, Becher, Peter Moritz, Schrage, Benedikt, Weimann, Jessica, Smits, Jacqueline, Magnussen, Christina, Reichenspurner, Hermann, Goßling, Alina, Rodrigus, Inez, Dumfarth, Julia, de Pauw, Michel, François, Katrien, Van Caenegem, Olivier, Ancion, Arnaut, Van Cleemput, Johan, Milicic, Davor, Moza, Ajay, Schenker, Peter, Röhrich, Luise, Schönrath, Felix, Thul, Josef, Steinmetz, Michael, Schmack, Bastian, Ruhparwar, Arjang, Warnecke, Gregor, Rojas, Sebastian V, Sandhaus, Tim, Haneya, Assad, Eifert, Sandra, Welp, Henryk, Ablonczy, László, Wagner, Florian, Westermann, Dirk, Bernhardt, Alexander M, Knappe, Dorit, Blankenberg, Stefan, Kirchhof, Paulus, Zengin, Elvin, Sinning, Christoph, UCL - SSS/IREC/MEDA - Pôle de médecine aiguë, UCL - (SLuc) Service de soins intensifs, Becher, Peter Moritz, Schrage, Benedikt, Weimann, Jessica, Smits, Jacqueline, Magnussen, Christina, Reichenspurner, Hermann, Goßling, Alina, Rodrigus, Inez, Dumfarth, Julia, de Pauw, Michel, François, Katrien, Van Caenegem, Olivier, Ancion, Arnaut, Van Cleemput, Johan, Milicic, Davor, Moza, Ajay, Schenker, Peter, Röhrich, Luise, Schönrath, Felix, Thul, Josef, Steinmetz, Michael, Schmack, Bastian, Ruhparwar, Arjang, Warnecke, Gregor, Rojas, Sebastian V, Sandhaus, Tim, Haneya, Assad, Eifert, Sandra, Welp, Henryk, Ablonczy, László, Wagner, Florian, Westermann, Dirk, Bernhardt, Alexander M, Knappe, Dorit, Blankenberg, Stefan, Kirchhof, Paulus, Zengin, Elvin, and Sinning, Christoph

Abstract

BACKGROUND: The therapeutic success in patients with congenital heart disease (CHD) leads to a growing number of adults with CHD (adult CHD [ACHD]) who develop end-stage heart failure. We aimed to determine patient characteristics and outcomes of ACHD listed for heart transplantation. METHODS: Using data from all the patients with ACHD in 20 transplant centers in the Eurotransplant region from 1999 to 2015, we analyzed patient characteristics, waiting list, and post-transplantation outcomes. RESULTS: A total of 204 patients with ACHD were listed during the study period. The median age was 38 years, and 62.3% of the patients were listed in high urgency (HU), and 37.7% of the patients were in transplantable (T)-listing status. A total of 23.5% of the patients died or were delisted owing to clinical worsening, and 75% of the patients underwent transplantation. Median waiting time for patients with HU-listing status was 4.18 months and with T-listing status 9.07 months. There was no difference in crude mortality or delisting between patients who were HU status listed and T status listed (p = 0.65). In multivariable regression analysis, markers for respiratory failure (mechanical ventilation, hazard ratio [HR]: 1.41, 95% CI: 1.11-1.81, p = 0.006) and arrhythmias (anti-arrhythmic medication, HR: 1.42, 95% CI: 1.01-2.01, p = 0.044) were associated with a higher risk of death or delisting. In the overall cohort, post-transplantation mortality was 26.8% after 1 year and 33.4% after 5 years. CONCLUSIONS: Listed patients are at high risk of death without differences in the urgency of listing. Respiratory failure requiring invasive ventilation and possibly arrhythmias requiring anti-arrhythmic medication indicate worse outcomes on waiting list.

Published
2020

10. Simulation Training to Improve Informed Consent and Pharmacokinetic/Pharmacodynamic Sampling in Pediatric Trials

Author

Cardiologie onderzoek 1, Child Health, Circulatory Health, Regenerative Medicine and Stem Cells, Burckhardt, Bjoern B., Ciplea, Agnes Maria, Laven, Anna, Ablonczy, László, Klingmann, Ingrid, Läer, Stephanie, Kleine, Karl, Dalinghaus, Michiel, Đukić, Milan, Breur, Johannes M.P.J., van der Meulen, Marijke, Swoboda, Vanessa, Schwender, Holger, Lagler, Florian B., Cardiologie onderzoek 1, Child Health, Circulatory Health, Regenerative Medicine and Stem Cells, Burckhardt, Bjoern B., Ciplea, Agnes Maria, Laven, Anna, Ablonczy, László, Klingmann, Ingrid, Läer, Stephanie, Kleine, Karl, Dalinghaus, Michiel, Đukić, Milan, Breur, Johannes M.P.J., van der Meulen, Marijke, Swoboda, Vanessa, Schwender, Holger, and Lagler, Florian B.

Published
2020

12. Pharmacotherapeutic management of paediatric heart failure and ACE-I use patterns: a European survey

Author

Castro Díez, Cristina, primary, Khalil, Feras, additional, Schwender, Holger, additional, Dalinghaus, Michiel, additional, Jovanovic, Ida, additional, Makowski, Nina, additional, Male, Christoph, additional, Bajcetic, Milica, additional, van der Meulen, Marijke, additional, de Wildt, Saskia N, additional, Ablonczy, László, additional, Szatmári, András, additional, Klingmann, Ingrid, additional, Walsh, Jennifer, additional, and Läer, Stephanie, additional

Published
2019
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