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, and MULLENS, Wilfried
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.