Treatment of Volume Overload in Acute Heart Failure Guided by Urinary Salt Assessment
- Conditions
- Acute Heart FailureMedDRA version: 20.0Level: LLTClassification code 10000803Term: Acute heart failureSystem Organ Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2021-005426-18-BE
- Lead Sponsor
- Z Brussel
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 104
•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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method