Cargando…

Rationale and Study Design of the Withdrawal of Spironolactone for Heart Failure with Improved Left Ventricular Ejection Fraction

It is unclear if guideline-directed medical therapy (GDMT) should be maintained in patients who have heart failure (HF) with improved ejection fraction (HFiEF). Of the medications recommended for HF, mineralocorticoid receptor antagonist (MRA) is associated with heterogeneous results and considerabl...

Descripción completa

Detalles Bibliográficos
Autores principales: Hyun, Junho, Lee, Sang Eun, Lee, Seung-Ah, Hong, Jung Ae, Kim, Min-Seok, Kim, Jae-Joong
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Korean Society of Heart Failure 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9536720/
https://www.ncbi.nlm.nih.gov/pubmed/36263115
http://dx.doi.org/10.36628/ijhf.2020.0044
_version_ 1784803041131626496
author Hyun, Junho
Lee, Sang Eun
Lee, Seung-Ah
Hong, Jung Ae
Kim, Min-Seok
Kim, Jae-Joong
author_facet Hyun, Junho
Lee, Sang Eun
Lee, Seung-Ah
Hong, Jung Ae
Kim, Min-Seok
Kim, Jae-Joong
author_sort Hyun, Junho
collection PubMed
description It is unclear if guideline-directed medical therapy (GDMT) should be maintained in patients who have heart failure (HF) with improved ejection fraction (HFiEF). Of the medications recommended for HF, mineralocorticoid receptor antagonist (MRA) is associated with heterogeneous results and considerable adverse events. We wish to evaluate whether MRA withdrawal is safe or associated with deterioration of left ventricular ejection fraction (LVEF). We will select 60 patients with HFiEF of a New York Heart Association functional class I–II who are receiving GDMT and randomize them in a 1:1 fashion into 2 groups: one that will continue treatment and one that will have spironolactone administration withdrawn. All patients will receive standard medical therapy other than MRA. The primary outcome is the proportion of patients with declining LVEF ≥10%. Secondary outcomes include a change in LVEF, the estimated glomerular filtration rate, B-type natriuretic peptide or N-terminal pro-brain natriuretic peptide levels, and adverse clinical events, including death, re-hospitalization, or an emergency department visit for HF. This trial will provide important evidence on whether MRA in addition to other standard therapy, should be maintained or withdrawn in patients with HFiEF.
format Online
Article
Text
id pubmed-9536720
institution National Center for Biotechnology Information
language English
publishDate 2021
publisher Korean Society of Heart Failure
record_format MEDLINE/PubMed
spelling pubmed-95367202022-10-18 Rationale and Study Design of the Withdrawal of Spironolactone for Heart Failure with Improved Left Ventricular Ejection Fraction Hyun, Junho Lee, Sang Eun Lee, Seung-Ah Hong, Jung Ae Kim, Min-Seok Kim, Jae-Joong Int J Heart Fail Trial Design It is unclear if guideline-directed medical therapy (GDMT) should be maintained in patients who have heart failure (HF) with improved ejection fraction (HFiEF). Of the medications recommended for HF, mineralocorticoid receptor antagonist (MRA) is associated with heterogeneous results and considerable adverse events. We wish to evaluate whether MRA withdrawal is safe or associated with deterioration of left ventricular ejection fraction (LVEF). We will select 60 patients with HFiEF of a New York Heart Association functional class I–II who are receiving GDMT and randomize them in a 1:1 fashion into 2 groups: one that will continue treatment and one that will have spironolactone administration withdrawn. All patients will receive standard medical therapy other than MRA. The primary outcome is the proportion of patients with declining LVEF ≥10%. Secondary outcomes include a change in LVEF, the estimated glomerular filtration rate, B-type natriuretic peptide or N-terminal pro-brain natriuretic peptide levels, and adverse clinical events, including death, re-hospitalization, or an emergency department visit for HF. This trial will provide important evidence on whether MRA in addition to other standard therapy, should be maintained or withdrawn in patients with HFiEF. Korean Society of Heart Failure 2021-01-14 /pmc/articles/PMC9536720/ /pubmed/36263115 http://dx.doi.org/10.36628/ijhf.2020.0044 Text en Copyright © 2021. Korean Society of Heart Failure https://creativecommons.org/licenses/by-nc/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (https://creativecommons.org/licenses/by-nc/4.0 (https://creativecommons.org/licenses/by-nc/4.0/) ) which permits unrestricted noncommercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Trial Design
Hyun, Junho
Lee, Sang Eun
Lee, Seung-Ah
Hong, Jung Ae
Kim, Min-Seok
Kim, Jae-Joong
Rationale and Study Design of the Withdrawal of Spironolactone for Heart Failure with Improved Left Ventricular Ejection Fraction
title Rationale and Study Design of the Withdrawal of Spironolactone for Heart Failure with Improved Left Ventricular Ejection Fraction
title_full Rationale and Study Design of the Withdrawal of Spironolactone for Heart Failure with Improved Left Ventricular Ejection Fraction
title_fullStr Rationale and Study Design of the Withdrawal of Spironolactone for Heart Failure with Improved Left Ventricular Ejection Fraction
title_full_unstemmed Rationale and Study Design of the Withdrawal of Spironolactone for Heart Failure with Improved Left Ventricular Ejection Fraction
title_short Rationale and Study Design of the Withdrawal of Spironolactone for Heart Failure with Improved Left Ventricular Ejection Fraction
title_sort rationale and study design of the withdrawal of spironolactone for heart failure with improved left ventricular ejection fraction
topic Trial Design
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9536720/
https://www.ncbi.nlm.nih.gov/pubmed/36263115
http://dx.doi.org/10.36628/ijhf.2020.0044
work_keys_str_mv AT hyunjunho rationaleandstudydesignofthewithdrawalofspironolactoneforheartfailurewithimprovedleftventricularejectionfraction
AT leesangeun rationaleandstudydesignofthewithdrawalofspironolactoneforheartfailurewithimprovedleftventricularejectionfraction
AT leeseungah rationaleandstudydesignofthewithdrawalofspironolactoneforheartfailurewithimprovedleftventricularejectionfraction
AT hongjungae rationaleandstudydesignofthewithdrawalofspironolactoneforheartfailurewithimprovedleftventricularejectionfraction
AT kimminseok rationaleandstudydesignofthewithdrawalofspironolactoneforheartfailurewithimprovedleftventricularejectionfraction
AT kimjaejoong rationaleandstudydesignofthewithdrawalofspironolactoneforheartfailurewithimprovedleftventricularejectionfraction