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

Z Brussel0 个研究点目标入组 104 人开始时间: 2021年10月25日最近更新: 2024年8月5日

适应症

试验速览

暂无简介。

•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
•F.1.2.1 Number of subjects for this age range 52
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 52

•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

发起方

Z Brussel