Rationale and Design of the Efficacy of a Standardized Diuretic Protocol in Acute Heart Failure Study

Aims Although acute heart failure (AHF) with volume overload is treated with loop diuretics, their dosing and type of administration are mainly based upon expert opinion. A recent position paper from the Heart Failure Association (HFA) proposed a step-wise pharmacologic diuretic strategy to increase...

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Autores: Dauw, J, Lelonek, M, Zegri-Reiriz, I, Paredes-Paucar, CP, Zara, C, George, V, Cobo-Marcos, M, Knappe, D, Shchekochikhin, D, Lekhakul, A, Klincheva, M, Frea, S, Miro, O, Barker, D, Borbely, A, Nasr, S, Doghmi, N, de la Espriella, R, Singh, JS, Bovolo, V, Fialho, I, Ross, NT, van den Heuvel, M, Benkouar, R, Findeisen, H, Alhaddad, IA, Al Balbissi, K, Barge-Caballero, G, Ghazi, AM, Bruckers, L, Martens, P, Mullens, W
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2021
País:España
Institución:Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau)
Repositorio:r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau
OAI Identifier:oai:iibsantpau.fundanetsuite.com:p4274
Acceso en línea:https://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=4274
https://ddd.uab.cat/record/270217
Access Level:acceso abierto
Palabra clave:Acute heart failure
Diuretics
Urinary sodium
Decongestion
Protocol
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spelling Rationale and Design of the Efficacy of a Standardized Diuretic Protocol in Acute Heart Failure StudyDauw, JLelonek, MZegri-Reiriz, IParedes-Paucar, CPZara, CGeorge, VCobo-Marcos, MKnappe, DShchekochikhin, DLekhakul, AKlincheva, MFrea, SMiro, OBarker, DBorbely, ANasr, SDoghmi, Nde la Espriella, RSingh, JSBovolo, VFialho, IRoss, NTvan den Heuvel, MBenkouar, RFindeisen, HAlhaddad, IAAl Balbissi, KBarge-Caballero, GGhazi, AMBruckers, LMartens, PMullens, WAcute heart failureDiureticsUrinary sodiumDecongestionProtocolAims Although acute heart failure (AHF) with volume overload is treated with loop diuretics, their dosing and type of administration are mainly based upon expert opinion. A recent position paper from the Heart Failure Association (HFA) proposed a step-wise pharmacologic diuretic strategy to increase the diuretic response and to achieve rapid decongestion. However, no study has evaluated this protocol prospectively. Methods and results The Efficacy of a Standardized Diuretic Protocol in Acute Heart Failure (ENACT-HF) study is an international, multicentre, non-randomized, open-label, pragmatic study in AHF patients on chronic loop diuretic therapy, admitted to the hospital for intravenous loop diuretic therapy, aiming to enrol 500 patients. Inclusion criteria are as follows: at least one sign of volume overload (oedema, ascites, or pleural effusion), use >= 40 mg of furosemide or equivalent for >1 month, and a BNP > 250 ng/L or an N-terminal pro-B-type natriuretic peptide > 1000 pg/L. The study is designed in two sequential phases. During Phase 1, all centres will treat consecutive patients according to the local standard of care. In the Phase 2 of the study, all centres will implement a standardized diuretic protocol in the next cohort of consecutive patients. The protocol is based upon the recently published HFA algorithm on diuretic use and starts with intravenous administration of two times the oral home dose. It includes early assessment of diuretic response with a spot urinary sodium measurement after 2 h and urine output after 6 h. Diuretics will be tailored further based upon these measurements. The study is powered for its primary endpoint of natriuresis after 1 day and will be able to detect a 15% difference with 80% power. Secondary endpoints are natriuresis and diuresis after 2 days, change in congestion score, change in weight, in-hospital mortality, and length of hospitalization. Conclusions The ENACT-HF study will investigate whether a step-wise diuretic approach, based upon early assessment of urinary sodium and urine output as proposed by the HFA, is feasible and able to improve decongestion in AHF with volume overload.WILEY PERIODICALS, INC2021info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=4274https://ddd.uab.cat/record/270217ESC Heart FailureISSN: 20555822reponame:r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pauinstname:Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau)Inglésinfo:eu-repo/semantics/openAccessoai:iibsantpau.fundanetsuite.com:p42742026-06-14T12:41:47Z
dc.title.none.fl_str_mv Rationale and Design of the Efficacy of a Standardized Diuretic Protocol in Acute Heart Failure Study
title Rationale and Design of the Efficacy of a Standardized Diuretic Protocol in Acute Heart Failure Study
spellingShingle Rationale and Design of the Efficacy of a Standardized Diuretic Protocol in Acute Heart Failure Study
Dauw, J
Acute heart failure
Diuretics
Urinary sodium
Decongestion
Protocol
title_short Rationale and Design of the Efficacy of a Standardized Diuretic Protocol in Acute Heart Failure Study
title_full Rationale and Design of the Efficacy of a Standardized Diuretic Protocol in Acute Heart Failure Study
title_fullStr Rationale and Design of the Efficacy of a Standardized Diuretic Protocol in Acute Heart Failure Study
title_full_unstemmed Rationale and Design of the Efficacy of a Standardized Diuretic Protocol in Acute Heart Failure Study
title_sort Rationale and Design of the Efficacy of a Standardized Diuretic Protocol in Acute Heart Failure Study
dc.creator.none.fl_str_mv Dauw, J
Lelonek, M
Zegri-Reiriz, I
Paredes-Paucar, CP
Zara, C
George, V
Cobo-Marcos, M
Knappe, D
Shchekochikhin, D
Lekhakul, A
Klincheva, M
Frea, S
Miro, O
Barker, D
Borbely, A
Nasr, S
Doghmi, N
de la Espriella, R
Singh, JS
Bovolo, V
Fialho, I
Ross, NT
van den Heuvel, M
Benkouar, R
Findeisen, H
Alhaddad, IA
Al Balbissi, K
Barge-Caballero, G
Ghazi, AM
Bruckers, L
Martens, P
Mullens, W
author Dauw, J
author_facet Dauw, J
Lelonek, M
Zegri-Reiriz, I
Paredes-Paucar, CP
Zara, C
George, V
Cobo-Marcos, M
Knappe, D
Shchekochikhin, D
Lekhakul, A
Klincheva, M
Frea, S
Miro, O
Barker, D
Borbely, A
Nasr, S
Doghmi, N
de la Espriella, R
Singh, JS
Bovolo, V
Fialho, I
Ross, NT
van den Heuvel, M
Benkouar, R
Findeisen, H
Alhaddad, IA
Al Balbissi, K
Barge-Caballero, G
Ghazi, AM
Bruckers, L
Martens, P
Mullens, W
author_role author
author2 Lelonek, M
Zegri-Reiriz, I
Paredes-Paucar, CP
Zara, C
George, V
Cobo-Marcos, M
Knappe, D
Shchekochikhin, D
Lekhakul, A
Klincheva, M
Frea, S
Miro, O
Barker, D
Borbely, A
Nasr, S
Doghmi, N
de la Espriella, R
Singh, JS
Bovolo, V
Fialho, I
Ross, NT
van den Heuvel, M
Benkouar, R
Findeisen, H
Alhaddad, IA
Al Balbissi, K
Barge-Caballero, G
Ghazi, AM
Bruckers, L
Martens, P
Mullens, W
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
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Acute heart failure
Diuretics
Urinary sodium
Decongestion
Protocol
topic Acute heart failure
Diuretics
Urinary sodium
Decongestion
Protocol
description Aims Although acute heart failure (AHF) with volume overload is treated with loop diuretics, their dosing and type of administration are mainly based upon expert opinion. A recent position paper from the Heart Failure Association (HFA) proposed a step-wise pharmacologic diuretic strategy to increase the diuretic response and to achieve rapid decongestion. However, no study has evaluated this protocol prospectively. Methods and results The Efficacy of a Standardized Diuretic Protocol in Acute Heart Failure (ENACT-HF) study is an international, multicentre, non-randomized, open-label, pragmatic study in AHF patients on chronic loop diuretic therapy, admitted to the hospital for intravenous loop diuretic therapy, aiming to enrol 500 patients. Inclusion criteria are as follows: at least one sign of volume overload (oedema, ascites, or pleural effusion), use >= 40 mg of furosemide or equivalent for >1 month, and a BNP > 250 ng/L or an N-terminal pro-B-type natriuretic peptide > 1000 pg/L. The study is designed in two sequential phases. During Phase 1, all centres will treat consecutive patients according to the local standard of care. In the Phase 2 of the study, all centres will implement a standardized diuretic protocol in the next cohort of consecutive patients. The protocol is based upon the recently published HFA algorithm on diuretic use and starts with intravenous administration of two times the oral home dose. It includes early assessment of diuretic response with a spot urinary sodium measurement after 2 h and urine output after 6 h. Diuretics will be tailored further based upon these measurements. The study is powered for its primary endpoint of natriuresis after 1 day and will be able to detect a 15% difference with 80% power. Secondary endpoints are natriuresis and diuresis after 2 days, change in congestion score, change in weight, in-hospital mortality, and length of hospitalization. Conclusions The ENACT-HF study will investigate whether a step-wise diuretic approach, based upon early assessment of urinary sodium and urine output as proposed by the HFA, is feasible and able to improve decongestion in AHF with volume overload.
publishDate 2021
dc.date.none.fl_str_mv 2021
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=4274
https://ddd.uab.cat/record/270217
url https://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=4274
https://ddd.uab.cat/record/270217
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv WILEY PERIODICALS, INC
publisher.none.fl_str_mv WILEY PERIODICALS, INC
dc.source.none.fl_str_mv ESC Heart Failure
ISSN: 20555822
reponame:r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau
instname:Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau)
instname_str Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau)
reponame_str r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau
collection r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau
repository.name.fl_str_mv
repository.mail.fl_str_mv
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