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

Authors :
Riad Benkouar
Kais Al Balbissi
Nawal Doghmi
Noel Thomas Ross
Wilfried Mullens
Simone Frea
Virginia Bovolo
Milka Klincheva
Małgorzata Lelonek
Azmee Mohd Ghazi
Cynthia P. Paredes-Paucar
Hajo Findeisen
Rafael de la Espriella
Mieke van den Heuvel
Isabel Zegri-Reiriz
Varghese George
Gonzalo Barge-Caballero
Imad A. Alhaddad
Samer Nasr
Òscar Miró
Pieter Martens
Liesbeth Bruckers
Marta Cobo-Marcos
Attila Borbély
Dmitry Shchekochikhin
Inês Fialho
Cornelia Zara
Dorit Knappe
Jeroen Dauw
Jagdeep Singh
Annop Lekhakul
Diane Barker
Shchekochikhin, Dmitry/0000-0002-8209-2791
Paredes Paucar
Cynthia/0000-0003-0734-6437
Dauw, Jeroen/0000-0003-4605-3450
Lelonek
Malgorzata/0000-0003-0756-5541
DAUW, Jeroen
Lelonek, Malgorzata
Zegri-Reiriz, Isabel
Paredes-Paucar, Cynthia P.
Zara, Cornelia
George, Varghese
Cobo-Marcos, Marta
Knappe, Dorit
Shchekochikhin, Dmitry
Lekhakul, Annop
Klincheva, Milka
Frea, Simone
Miro, Oscar
Barker, Diane
Borbely, Attila
Nasr, Samer
Doghmi, Nawal
de la Espriella, Rafael
Singh, Jagdeep S.
Bovolo, Virginia
Fialho, Ines
Ross, Noel T.
van den Heuvel, Marcel
Benkouar, Riad
Findeisen, Hajo
Alhaddad, Imad A.
Al Balbissi, Kais
Barge-Caballero, Gonzalo
Ghazi, Azmee M.
BRUCKERS, Liesbeth
MARTENS, Pieter
MULLENS, Wilfried
Source :
ESC Heart Failure, Vol 8, Iss 6, Pp 4685-4692 (2021), Esc Heart Failure, r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA, instname, ESC Heart Failure, r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau
Publication Year :
2021
Publisher :
Wiley, 2021.

Abstract

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=40mg of furosemide or equivalent for >1month, and a BNP>250ng/L or an N-terminal pro-B-type natriuretic peptide>1000pg/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 2h and urine output after 6h. Diuretics will be tailored further based upon these measurements. The study is powered for its primary endpoint of natriuresis after 1day and will be able to detect a 15% difference with 80% power. Secondary endpoints are natriuresis and diuresis after 2days, 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.

Details

Language :
English
ISSN :
20555822
Volume :
8
Issue :
6
Database :
OpenAIRE
Journal :
ESC Heart Failure
Accession number :
edsair.doi.dedup.....0de301bc7df6070989bc8f7ae12bd022