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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...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Korean Society of Heart Failure
2021
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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 |
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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in a 1:1 fashion into 2 groups: one that will continue treatment and one that will have spironolactone administration withdrawn.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trial will provide important evidence on whether MRA in addition to other standard therapy, should be maintained or withdrawn in patients with HFiEF.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 |
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