Rationale and design of a multicentre, randomized,placebo-controlled trial of mirabegron, a Beta3-adrenergic receptor agonist on left ventricular massand diastolic function in patients with structural heartdisease Beta3-left ventricular hypertrophy (Beta3-LVH)
| Autor(a) principal: | |
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| Data de Publicação: | 2018 |
| Outros Autores: | , , , , , , , , , , , , , , , , , , , , , , , |
| Tipo de documento: | Artigo |
| Idioma: | eng |
| Título da fonte: | Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
| Texto Completo: | http://hdl.handle.net/10451/35178 |
Resumo: | © 2018 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of the European Society of Cardiology. This is an open access article under the terms of the Creative Commons Attribution‐Non Commercial‐No Derivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made. |
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Rationale and design of a multicentre, randomized,placebo-controlled trial of mirabegron, a Beta3-adrenergic receptor agonist on left ventricular massand diastolic function in patients with structural heartdisease Beta3-left ventricular hypertrophy (Beta3-LVH)β3 adrenergic receptorMirabegronHypertensive structural heart diseaseHeart failure with preserved ejection fraction© 2018 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of the European Society of Cardiology. This is an open access article under the terms of the Creative Commons Attribution‐Non Commercial‐No Derivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.Aims: Progressive left ventricular (LV) remodelling with cardiac myocyte hypertrophy, myocardial fibrosis, and endothelial dysfunction plays a key role in the onset and progression of heart failure with preserved ejection fraction. The Beta3‐LVH trial will test the hypothesis that the β3 adrenergic receptor agonist mirabegron will improve LV hypertrophy and diastolic function in patients with hypertensive structural heart disease at high risk for developing heart failure with preserved ejection fraction. Methods and results: Beta3‐LVH is a randomized, placebo‐controlled, double‐blind, two‐armed, multicentre, European, parallel group study. A total of 296 patients will be randomly assigned to receive either mirabegron 50 mg daily or placebo over 12 months. The main inclusion criterion is the presence of LV hypertrophy, that is, increased LV mass index (LVMi) or increased wall thickening by echocardiography. The co‐primary endpoints are a change in LVMi by cardiac magnetic resonance imaging and a change in LV diastolic function (assessed by the E/e′ ratio). Secondary endpoints include mirabegron's effects on cardiac fibrosis, left atrial volume index, maximal exercise capacity, and laboratory markers. Two substudies will evaluate mirabegron's effect on endothelial function by pulse amplitude tonometry and brown fat activity by positron emission tomography using 17F‐fluorodeoxyglucose. Morbidity and mortality as well as safety aspects will also be assessed. Conclusions: Beta3‐LVH is the first large‐scale clinical trial to evaluate the effects of mirabegron on LVMi and diastolic function in patients with LVH. Beta3‐LVH will provide important information about the clinical course of this condition and may have significant impact on treatment strategies and future trials in these patients.This work was funded by the European Union Horizon 2020 grant (UE LSHM‐CT‐05‐018833) to J.‐L.B. B.C. is supported by the British Heart Foundation (RG/11/15/29375), the National Institute for Health Research Biomedical Research Centre, Oxford, the European Union's Horizon 2020 research and innovation programme (grant number 633196[CATCH ME]), and the British Heart Foundation Centre of Research Excellence, Oxford (grant number RE/08/004). S.P. and S.N. are supported by the NIHR Biomedical Research Centre, Oxford. They also acknowledge the support from the British Heart Foundation Centre of Research Excellence, Oxford, UK (RE/08/004 to R.W.). A.‐C.P. is sponsored by a Post‐doctorate Clinical Master Specialist of the Fondation Nationale de la Recherche Scientifique of the Belgian Government (FRSM: SPD 10844948).Wiley Open AccessRepositório da Universidade de LisboaPouleur, Anne-CatherineAnker, StefanBrito, DulceBrosteanu, OanaHasenclever, DirkCasadei, BarbaraEdelmann, FrankFilippatos, GerasimosGruson, DamienIkonomidis, IgnatiosLhommel, RenaudMahmod, MaslizaNeubauer, StefanPersu, AlexandreGerber, Bernhard L.Piechnik, StefanPieske, BurkertKraigher, Elisabeth PieskePinto, Fausto J.Ponikowski, PiotrSenni, MicheleTrochu, Jean-NoëlVan Overstraeten, NancyWachter, RolfBalligand, Jean-Luc2018-10-22T13:06:04Z20182018-01-01T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfhttp://hdl.handle.net/10451/35178engESC Heart Failure 2018; 5: 831–8422055-582210.1002/ehf2.12306info:eu-repo/semantics/openAccessreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAP2023-11-08T16:30:57Zoai:repositorio.ul.pt:10451/35178Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-19T21:49:41.774493Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãofalse |
| dc.title.none.fl_str_mv |
Rationale and design of a multicentre, randomized,placebo-controlled trial of mirabegron, a Beta3-adrenergic receptor agonist on left ventricular massand diastolic function in patients with structural heartdisease Beta3-left ventricular hypertrophy (Beta3-LVH) |
| title |
Rationale and design of a multicentre, randomized,placebo-controlled trial of mirabegron, a Beta3-adrenergic receptor agonist on left ventricular massand diastolic function in patients with structural heartdisease Beta3-left ventricular hypertrophy (Beta3-LVH) |
| spellingShingle |
Rationale and design of a multicentre, randomized,placebo-controlled trial of mirabegron, a Beta3-adrenergic receptor agonist on left ventricular massand diastolic function in patients with structural heartdisease Beta3-left ventricular hypertrophy (Beta3-LVH) Pouleur, Anne-Catherine β3 adrenergic receptor Mirabegron Hypertensive structural heart disease Heart failure with preserved ejection fraction |
| title_short |
Rationale and design of a multicentre, randomized,placebo-controlled trial of mirabegron, a Beta3-adrenergic receptor agonist on left ventricular massand diastolic function in patients with structural heartdisease Beta3-left ventricular hypertrophy (Beta3-LVH) |
| title_full |
Rationale and design of a multicentre, randomized,placebo-controlled trial of mirabegron, a Beta3-adrenergic receptor agonist on left ventricular massand diastolic function in patients with structural heartdisease Beta3-left ventricular hypertrophy (Beta3-LVH) |
| title_fullStr |
Rationale and design of a multicentre, randomized,placebo-controlled trial of mirabegron, a Beta3-adrenergic receptor agonist on left ventricular massand diastolic function in patients with structural heartdisease Beta3-left ventricular hypertrophy (Beta3-LVH) |
| title_full_unstemmed |
Rationale and design of a multicentre, randomized,placebo-controlled trial of mirabegron, a Beta3-adrenergic receptor agonist on left ventricular massand diastolic function in patients with structural heartdisease Beta3-left ventricular hypertrophy (Beta3-LVH) |
| title_sort |
Rationale and design of a multicentre, randomized,placebo-controlled trial of mirabegron, a Beta3-adrenergic receptor agonist on left ventricular massand diastolic function in patients with structural heartdisease Beta3-left ventricular hypertrophy (Beta3-LVH) |
| author |
Pouleur, Anne-Catherine |
| author_facet |
Pouleur, Anne-Catherine Anker, Stefan Brito, Dulce Brosteanu, Oana Hasenclever, Dirk Casadei, Barbara Edelmann, Frank Filippatos, Gerasimos Gruson, Damien Ikonomidis, Ignatios Lhommel, Renaud Mahmod, Masliza Neubauer, Stefan Persu, Alexandre Gerber, Bernhard L. Piechnik, Stefan Pieske, Burkert Kraigher, Elisabeth Pieske Pinto, Fausto J. Ponikowski, Piotr Senni, Michele Trochu, Jean-Noël Van Overstraeten, Nancy Wachter, Rolf Balligand, Jean-Luc |
| author_role |
author |
| author2 |
Anker, Stefan Brito, Dulce Brosteanu, Oana Hasenclever, Dirk Casadei, Barbara Edelmann, Frank Filippatos, Gerasimos Gruson, Damien Ikonomidis, Ignatios Lhommel, Renaud Mahmod, Masliza Neubauer, Stefan Persu, Alexandre Gerber, Bernhard L. Piechnik, Stefan Pieske, Burkert Kraigher, Elisabeth Pieske Pinto, Fausto J. Ponikowski, Piotr Senni, Michele Trochu, Jean-Noël Van Overstraeten, Nancy Wachter, Rolf Balligand, Jean-Luc |
| author2_role |
author author author author author author author author author author author author author author author author author author author author author author author author |
| dc.contributor.none.fl_str_mv |
Repositório da Universidade de Lisboa |
| dc.contributor.author.fl_str_mv |
Pouleur, Anne-Catherine Anker, Stefan Brito, Dulce Brosteanu, Oana Hasenclever, Dirk Casadei, Barbara Edelmann, Frank Filippatos, Gerasimos Gruson, Damien Ikonomidis, Ignatios Lhommel, Renaud Mahmod, Masliza Neubauer, Stefan Persu, Alexandre Gerber, Bernhard L. Piechnik, Stefan Pieske, Burkert Kraigher, Elisabeth Pieske Pinto, Fausto J. Ponikowski, Piotr Senni, Michele Trochu, Jean-Noël Van Overstraeten, Nancy Wachter, Rolf Balligand, Jean-Luc |
| dc.subject.por.fl_str_mv |
β3 adrenergic receptor Mirabegron Hypertensive structural heart disease Heart failure with preserved ejection fraction |
| topic |
β3 adrenergic receptor Mirabegron Hypertensive structural heart disease Heart failure with preserved ejection fraction |
| description |
© 2018 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of the European Society of Cardiology. This is an open access article under the terms of the Creative Commons Attribution‐Non Commercial‐No Derivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made. |
| publishDate |
2018 |
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2018-10-22T13:06:04Z 2018 2018-01-01T00:00:00Z |
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info:eu-repo/semantics/publishedVersion |
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info:eu-repo/semantics/article |
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article |
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publishedVersion |
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http://hdl.handle.net/10451/35178 |
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http://hdl.handle.net/10451/35178 |
| dc.language.iso.fl_str_mv |
eng |
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eng |
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ESC Heart Failure 2018; 5: 831–842 2055-5822 10.1002/ehf2.12306 |
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info:eu-repo/semantics/openAccess |
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openAccess |
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application/pdf |
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Wiley Open Access |
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Wiley Open Access |
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