Rationale and Design of the Efficacy of a Standardized Diuretic Protocol in Acute Heart Failure Study
Por:
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
Publicada:
1 dic 2021
Ahead of Print:
1 oct 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.
Filiaciones:
Dauw, J:
Ziekenhuis Oost Limburg, Dept Cardiol, Schiepse Bos 6, B-3600 Genk, Belgium
UHasselt Hasselt Univ, Doctoral Sch Med & Life Sci, LCRC, Diepenbeek, Belgium
Lelonek, M:
Med Univ Lodz, Dept Noninvas Cardiol, Lodz, Poland
Zegri-Reiriz, I:
Hosp Santa Creu & Sant Pau, Heart Failure & Heart Transplant Unit, Dept Cardiol, Barcelona, Spain
Paredes-Paucar, CP:
Inst Nacl Cardiol Ignacio Chavez, Ciudad De Mexico, Mexico
Zara, C:
Theracardia Clin, Brasov, Romania
George, V:
Pushpagiri Inst Med Sci, Tiruvalla, India
Cobo-Marcos, M:
Hosp Univ Puerta Hierro, Dept Cardiol, Madrid, Spain
Knappe, D:
Ctr Invest Biomed Red, Madrid, Spain
Univ Heart & Vasc Ctr Hamburg, Dept Cardiol, Hamburg, Germany
Shchekochikhin, D:
First Moscow State Med Univ, Dept Cardiol Sonog & Funct Diagnost, Moscow, Russia
Lekhakul, A:
Wetchakarunrasm Hosp, Bangkok, Thailand
Klincheva, M:
Zan Mitrev Clin, Skopje, North Macedonia
Frea, S:
Citta Salute & Sci Univ Hosp Torino, Div Cardiol, Turin, Italy
Miro, O:
Univ Barcelona, Emergency Dept, IDIBAPS, Barcelona, Spain
Barker, D:
Univ Hosp North Midlands, Stoke On Trent, Staffs, England
Borbely, A:
Univ Debrecen, Fac Med, Dept Cardiol, Debrecen, Hungary
Nasr, S:
Balamand Univ, Dept Cardiol, Mt Lebanon Hosp, Med Ctr, Hozmiyeh, Lebanon
Doghmi, N:
Mohammed V Univ, Dept Cardiol, CHU Ibn Sina, Rabat, Morocco
de la Espriella, R:
Hosp Clin Univ Valencia, Cardiol Dept, Valencia, Spain
Singh, JS:
Royal Infirm Edinburgh NHS Trust, Heart Ctr, Edinburgh, Midlothian, Scotland
Bovolo, V:
Michele & Pietro Ferrero Hosp, Dept Cardiol, Verduno, Italy
Fialho, I:
Hosp Prof Doutor Fernando Fonseca, Dept Cardiol, Amadora, Portugal
Ross, NT:
Kuala Lumpur Gen Hosp, Kuala Lumpur, Malaysia
van den Heuvel, M:
Thorax Ctr Twente, Dept Cardiol, Med Spectrum Twente, Enschede, Netherlands
Benkouar, R:
Univ Algiers, Mustapha Pacha Hosp, Benyoucef Benkhedda Fac Med, Algiers, Algeria
Findeisen, H:
Red Cross Hosp, Dept Internal Med, Bremen, Germany
Alhaddad, IA:
Jordan Hosp, Amman, Jordan
Al Balbissi, K:
Abdali Hosp, Dept Cardiol, Amman, Jordan
Barge-Caballero, G:
Complexo Hosp Univ A Coruna CHUAC, Inst Invest Biomed A Coruna INIBIC, Serv Galego Saude SERGAS, La Coruna, Spain
Ghazi, AM:
Inst Salud Carlos III, Ctr Invest Biomed Red Enfermedades Cardiovasc CIB, Madrid, Spain
Natl Heart Inst, Kuala Lumpur, Malaysia
Bruckers, L:
Hasselt Univ, Data Sci Inst, I BioStat, Diepenbeek, Belgium
Martens, P:
Ziekenhuis Oost Limburg, Dept Cardiol, Schiepse Bos 6, B-3600 Genk, Belgium
Mullens, W:
Ziekenhuis Oost Limburg, Dept Cardiol, Schiepse Bos 6, B-3600 Genk, Belgium
UHasselt, Biomed Res Inst, Fac Med & Life Sci, LCRC, Diepenbeek, Belgium
gold, Green Published
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