Diuretic Treatment in Acute Heart Failure with Volume Overload Guided by Serial Spot Urine Sodium Assessment - DECONGEST study

Z Brussel0 sites104 target enrollmentOctober 25, 2021

Overview

No summary available.

Registry

who.int

Start Date

October 25, 2021

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Z Brussel

•At least 18 y/o and able to provide informed consent
•Hospital admission (anticipated stay \>24 h after randomisation) with diagnosis of AHF according to the treating physician
•At least one of the following three signs of volume overload:
•1\) bilateral oedema 2\+, indicating clear pitting
•2\) ascites that is amenable for drainage, confirmed by echography
•3\) uni\- or bilateral pleural effusions that are amenable for drainage, confirmed by chest X\-ray or lung ultrasound
•Plasma N\-terminal of the pro hormone of B type natriuretic peptide (NTproBNP) level \>1,000 ng/L
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes

•No possibility to collect reliable urine spot samples after diuretic administration
•Administration of any diuretic within 6 h before randomisation, except for a mineralocorticoid receptor antagonist (MRA) or sodium glucose co transporter 2 (SGLT2\) inhibitor as part of the patient’s maintenance treatment for heart failure
•Severe kidney dysfunction, defined as an estimated glomerular filtration rate (eGFR) \<15 mL/min/1\.73m² calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) formula9 at randomisation, and/or previous, current, or planned future renal replacement therapy
•Systolic blood pressure \<90 mmHg, mean arterial pressure \<65 mmHg, or need for inotropes/vasopressor therapy at randomisation
•Any acute coronary syndrome within 30 days prior to enrolment, defined as typical chest pain with a troponin rise above the 99th percentile of normal and/or electrocardiographic changes suggestive of cardiac ischemia
•History of heart or kidney transplantation
•History of mechanical circulatory support
•Known obstructive hypertrophic cardiomyopathy, congenital heart disease, acute mechanical cause of AHF (e.g., papillary muscular rupture), acute myocarditis, or constrictive pericarditis
•Pregnant or breastfeeding woman
•Concomitant participation in another interventional study