Rationale and Design of the Efficacy of a Standardized Diuretic Protocol in Acute Heart Failure Study
Dauw, Jeroen (UHasselt-Hasselt University. Doctoral School for Medicine and Life Sciences. LCRC)
Lelonek, Malgorzata (Department of Noninvasive Cardiology. Medical University of Lodz)
Zegrí-Reiriz, Isabel (Institut d'Investigació Biomèdica Sant Pau)
Paredes-Paucar, Cynthia P. (Instituto Nacional de Cardiología Ignacio Chávez)
Zara, Cornelia (Theracardia Clinic)
George, Varghese (Pushpagiri Institute of Medical Sciences)
Cobo-Marcos, Marta (Hospital Universitario Puerta de Hierro Majadahonda (Madrid))
Knappe, Dorit (Department of Cardiology. University Heart and Vascular Center Hamburg)
Shchekochikhin, Dimitry (Department of cardiology. sonography and functional diagnostics. First Moscow State Medical University)
Lekhakul, Annop (Wetchakarunrasm Hospital)
Klincheva, Milka (Zan Mitrev Clinic)
Frea, Simone (Division of Cardiology. Città della Salute e della Scienza University Hospital of Torino)
Miró, Oscar (Institut d'Investigacions Biomèdiques August Pi i Sunyer)
Barker, Diane (University Hospitals of North Midlands)
Borbély, Attila (Department of Cardiology. Faculty of Medicine. University of Debrecen)
Nasr, Samer (Department of Cardiology. Mount Lebanon Hospital-Balamand University Medical Center)
Doghmi, Nawal (Department of Cardiology. CHU Ibn Sina. Mohammed V University)
De la Espriella, Rafael (Hospital Clínic Universitari (València))
Singh, Jagdeep S. (The Heart Centre. Royal Infirmary of Edinburgh)
Bovolo, Virginia (Department of Cardiology. Michele e Pietro Ferrero Hospital)
Fialho, Inês (Department of Cardiology. Hospital Doutor Fernando Fonseca)
Ross, Noel T. (Kuala Lumpur General Hospital)
van den Heuvel, Mieke (Department of Cardiology. Thorax Centrum Twente. Medisch Spectrum Twente)
Benkouar, Riad (Benyoucef Benkhedda Faculty of Medicine. Mustapha Pacha Hospital. University of Algiers)
Findeisen, Hajo (Department of Internal Medicine. Red Cross Hospital)
Alhaddad, Imad A. (Jordan Hospital)
Al Balbissi, Kais (Department of Cardiology. Abdali Hospital)
Barge-Caballero, Gonzalo (Instituto de Investigación Biomédica de A Coruña)
Ghazi, Azmee M. (National Heart Institute)
Bruckers, Liesbeth (I-BioStat. Data Science Institute. Hasselt University)
Martens, Pieter (Department of Cardiology. Ziekenhuis Oost-Limburg)
Mullens, Wilfried (Faculty of Medicine and Life Sciences. LCRC. UHasselt. Biomedical Research Institute)
Universitat Autònoma de Barcelona

Fecha:	2021
Resumen:	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.
Derechos:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.
Lengua:	Anglès
Documento:	Article ; recerca ; Versió publicada
Materia:	Diuretics ; Furosemide ; Heart Failure ; Humans ; Infusions, Intravenous ; Sodium Potassium Chloride Symporter Inhibitors ; Acute heart failure ; Urinary sodium ; Decongestion ; Protocol
Publicado en:	ESC Heart Failure, Vol. 8 Núm. 6 (december 2021) , p. 4685-4692, ISSN 2055-5822

DOI: 10.1002/ehf2.13666
PMID: 34708555

8 p, 5.6 MB

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