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

TY - JOUR

T1 - Rationale and Design of the Efficacy of a Standardized Diuretic Protocol in Acute Heart Failure Study

AU - Dauw, Jeroen

AU - Lelonek, Malgorzata

AU - Zegri-Reiriz, Isabel

AU - Paredes-Paucar, Cynthia P

AU - Zara, Cornelia

AU - George, Varghese

AU - Cobo-Marcos, Marta

AU - Knappe, Dorit

AU - Shchekochikhin, Dmitry

AU - Lekhakul, Annop

AU - Klincheva, Milka

AU - Frea, Simone

AU - Miró, Òscar

AU - Barker, Diane

AU - Borbély, Attila

AU - Nasr, Samer

AU - Doghmi, Nawal

AU - de la Espriella, Rafael

AU - Singh, Jagdeep S

AU - Bovolo, Virginia

AU - Fialho, Inês

AU - Ross, Noel T

AU - van den Heuvel, Mieke

AU - Benkouar, Riad

AU - Findeisen, Hajo

AU - Alhaddad, Imad A

AU - Al Balbissi, Kais

AU - Barge-Caballero, Gonzalo

AU - Ghazi, Azmee M

AU - Bruckers, Liesbeth

AU - Martens, Pieter

AU - Mullens, Wilfried

N1 - © 2021 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.

PY - 2021/12

Y1 - 2021/12

N2 - 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.

AB - 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.

U2 - 10.1002/ehf2.13666

DO - 10.1002/ehf2.13666

M3 - SCORING: Journal article

C2 - 34708555

VL - 8

SP - 4685

EP - 4692

JO - ESC HEART FAIL

JF - ESC HEART FAIL

SN - 2055-5822

IS - 6

ER -