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Rationale and Design of the Efficacy of a Standardized Diuretic Protocol in Acute Heart Failure Study
- 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.
- Subjects :
- medicine.drug_class
medicine.medical_treatment
Study Designs
Decongestion
Volume overload
Diuresis
Natriuresis
Sodium Potassium Chloride Symporter Inhibitors
Furosemide
Acute heart failure
Diuretics
Urinary sodium
Protocol
medicine
Clinical endpoint
Humans
Diseases of the circulatory (Cardiovascular) system
Infusions, Intravenous
Heart Failure
Study Design
business.industry
Loop diuretic
medicine.disease
Anesthesia
Heart failure
RC666-701
Diuretic
Cardiology and Cardiovascular Medicine
business
medicine.drug
Subjects
Details
- Language :
- English
- ISSN :
- 20555822
- Volume :
- 8
- Issue :
- 6
- Database :
- OpenAIRE
- Journal :
- ESC Heart Failure
- Accession number :
- edsair.doi.dedup.....0de301bc7df6070989bc8f7ae12bd022