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Serelaxin in addition to standard therapy in acute heart failure: rationale and design of the RELAX‐AHF‐2 study

Patients admitted for acute heart failure (AHF) experience high rates of in‐hospital and post‐discharge morbidity and mortality despite current therapies. Serelaxin is recombinant human relaxin‐2, a hormone with vasodilatory and end‐organ protective effects believed to play a central role in the car...

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Autores principales: Teerlink, John R., Voors, Adriaan A., Ponikowski, Piotr, Pang, Peter S., Greenberg, Barry H., Filippatos, Gerasimos, Felker, G. Michael, Davison, Beth A., Cotter, Gad, Gimpelewicz, Claudio, Boer‐Martins, Leandro, Wernsing, Margaret, Hua, Tsushung A., Severin, Thomas, Metra, Marco
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley & Sons, Ltd 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5488179/
https://www.ncbi.nlm.nih.gov/pubmed/28452195
http://dx.doi.org/10.1002/ejhf.830
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author Teerlink, John R.
Voors, Adriaan A.
Ponikowski, Piotr
Pang, Peter S.
Greenberg, Barry H.
Filippatos, Gerasimos
Felker, G. Michael
Davison, Beth A.
Cotter, Gad
Gimpelewicz, Claudio
Boer‐Martins, Leandro
Wernsing, Margaret
Hua, Tsushung A.
Severin, Thomas
Metra, Marco
author_facet Teerlink, John R.
Voors, Adriaan A.
Ponikowski, Piotr
Pang, Peter S.
Greenberg, Barry H.
Filippatos, Gerasimos
Felker, G. Michael
Davison, Beth A.
Cotter, Gad
Gimpelewicz, Claudio
Boer‐Martins, Leandro
Wernsing, Margaret
Hua, Tsushung A.
Severin, Thomas
Metra, Marco
author_sort Teerlink, John R.
collection PubMed
description Patients admitted for acute heart failure (AHF) experience high rates of in‐hospital and post‐discharge morbidity and mortality despite current therapies. Serelaxin is recombinant human relaxin‐2, a hormone with vasodilatory and end‐organ protective effects believed to play a central role in the cardiovascular and renal adaptations of human pregnancy. In the phase 3 RELAX‐AHF trial, serelaxin met its primary endpoint of improving dyspnoea through day 5 in patients admitted for AHF. Compared to placebo, serelaxin also reduced worsening heart failure (WHF) by 47% through day 5 and both all‐cause and cardiovascular mortality by 37% through day 180. RELAX‐AHF‐2 ( ClinicalTrials.gov NCT01870778) is designed to confirm serelaxin's effect on these clinical outcomes. RELAX‐AHF‐2 is a multicentre, randomized, double‐blind, placebo‐controlled, event‐driven, phase 3 trial enrolling ∼6800 patients hospitalized for AHF with dyspnoea, congestion on chest radiograph, increased natriuretic peptide levels, mild‐to‐moderate renal insufficiency, and systolic blood pressure ≥125 mmHg. Patients are randomized within 16 h of presentation to 48 h intravenous infusions of serelaxin (30 µg/kg/day) or placebo, both in addition to standard of care treatments. The primary objectives are to demonstrate that serelaxin is superior to placebo in reducing: (i) 180 day cardiovascular death, and (ii) occurrence of WHF through day 5. Key secondary endpoints include 180 day all‐cause mortality, composite of 180 day combined cardiovascular mortality or heart failure/renal failure rehospitalization, and in‐hospital length of stay during index AHF. The results from RELAX‐AHF‐2 will provide data on the potential beneficial effect of serelaxin on cardiovascular mortality and WHF in selected patients with AHF.
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spelling pubmed-54881792017-07-13 Serelaxin in addition to standard therapy in acute heart failure: rationale and design of the RELAX‐AHF‐2 study Teerlink, John R. Voors, Adriaan A. Ponikowski, Piotr Pang, Peter S. Greenberg, Barry H. Filippatos, Gerasimos Felker, G. Michael Davison, Beth A. Cotter, Gad Gimpelewicz, Claudio Boer‐Martins, Leandro Wernsing, Margaret Hua, Tsushung A. Severin, Thomas Metra, Marco Eur J Heart Fail Trial Design Patients admitted for acute heart failure (AHF) experience high rates of in‐hospital and post‐discharge morbidity and mortality despite current therapies. Serelaxin is recombinant human relaxin‐2, a hormone with vasodilatory and end‐organ protective effects believed to play a central role in the cardiovascular and renal adaptations of human pregnancy. In the phase 3 RELAX‐AHF trial, serelaxin met its primary endpoint of improving dyspnoea through day 5 in patients admitted for AHF. Compared to placebo, serelaxin also reduced worsening heart failure (WHF) by 47% through day 5 and both all‐cause and cardiovascular mortality by 37% through day 180. RELAX‐AHF‐2 ( ClinicalTrials.gov NCT01870778) is designed to confirm serelaxin's effect on these clinical outcomes. RELAX‐AHF‐2 is a multicentre, randomized, double‐blind, placebo‐controlled, event‐driven, phase 3 trial enrolling ∼6800 patients hospitalized for AHF with dyspnoea, congestion on chest radiograph, increased natriuretic peptide levels, mild‐to‐moderate renal insufficiency, and systolic blood pressure ≥125 mmHg. Patients are randomized within 16 h of presentation to 48 h intravenous infusions of serelaxin (30 µg/kg/day) or placebo, both in addition to standard of care treatments. The primary objectives are to demonstrate that serelaxin is superior to placebo in reducing: (i) 180 day cardiovascular death, and (ii) occurrence of WHF through day 5. Key secondary endpoints include 180 day all‐cause mortality, composite of 180 day combined cardiovascular mortality or heart failure/renal failure rehospitalization, and in‐hospital length of stay during index AHF. The results from RELAX‐AHF‐2 will provide data on the potential beneficial effect of serelaxin on cardiovascular mortality and WHF in selected patients with AHF. John Wiley & Sons, Ltd 2017-04-28 2017-06 /pmc/articles/PMC5488179/ /pubmed/28452195 http://dx.doi.org/10.1002/ejhf.830 Text en © 2017 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial (http://creativecommons.org/licenses/by-nc/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
spellingShingle Trial Design
Teerlink, John R.
Voors, Adriaan A.
Ponikowski, Piotr
Pang, Peter S.
Greenberg, Barry H.
Filippatos, Gerasimos
Felker, G. Michael
Davison, Beth A.
Cotter, Gad
Gimpelewicz, Claudio
Boer‐Martins, Leandro
Wernsing, Margaret
Hua, Tsushung A.
Severin, Thomas
Metra, Marco
Serelaxin in addition to standard therapy in acute heart failure: rationale and design of the RELAX‐AHF‐2 study
title Serelaxin in addition to standard therapy in acute heart failure: rationale and design of the RELAX‐AHF‐2 study
title_full Serelaxin in addition to standard therapy in acute heart failure: rationale and design of the RELAX‐AHF‐2 study
title_fullStr Serelaxin in addition to standard therapy in acute heart failure: rationale and design of the RELAX‐AHF‐2 study
title_full_unstemmed Serelaxin in addition to standard therapy in acute heart failure: rationale and design of the RELAX‐AHF‐2 study
title_short Serelaxin in addition to standard therapy in acute heart failure: rationale and design of the RELAX‐AHF‐2 study
title_sort serelaxin in addition to standard therapy in acute heart failure: rationale and design of the relax‐ahf‐2 study
topic Trial Design
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5488179/
https://www.ncbi.nlm.nih.gov/pubmed/28452195
http://dx.doi.org/10.1002/ejhf.830
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