Status:
COMPLETED
Diuretic Treatment in Acute Heart Failure With Volume Overload Guided by Serial Spot Urine Sodium Assessment
Lead Sponsor:
Vrije Universiteit Brussel
Collaborating Sponsors:
Roche Diagnostics GmbH
Jessa Hospital
Conditions:
Acute Heart Failure
Diuretics Drug Reactions
Eligibility:
All Genders
18-99 years
Phase:
PHASE4
Brief Summary
This is a pragmatic, multicenter, interventional, parallel-arm, randomized, open-label trial to investigate whether a diuretic regimen, based on serial assessment of sodium concentration (UNa) on spot...
Detailed Description
Key interventions are: * Assessment of UNa in spot urine samples after every bolus administration of loop diuretics with continuation of intravenous diuretics until resolution of clinical signs of fl...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- At least 18 y/o and able to provide informed consent
- Hospital admission (anticipated stay \>24 h after randomisation) with diagnosis of acute heart failure according to the treating physician
- At least one of the following three signs of volume overload:
- bilateral oedema 2+, indicating clear pitting
- ascites that is amenable for drainage, confirmed by echography (no obligation to perform abdominal echocardiography, but necessary when presence of ascites is used as an entry criterion for the study)
- uni- or bilateral pleural effusions that are amenable for drainage, confirmed by chest X-ray or lung ultrasound (no obligation to perform chest X-ray, but necessary when presence of pleural effusions is used as an entry criterion for the study)
- Plasma NTproBNP level \>1,000 ng/L
- Exclusion criteria:
- 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 or sodium glucose co-transporter-2 inhibitor as part of the patient's maintenance treatment for heart failure. Patients can still be included after withholding these diuretics for 6 h, after which randomisation can be performed if they qualify all other criteria.
- Severe kidney dysfunction, defined as an eGFR \<15 mL/min/1.73m² calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula 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 acute heart failure (e.g., papillary muscular rupture), acute myocarditis, or constrictive pericarditis according to the treating physician
- Pregnant or breastfeeding woman
- Concomitant participation in another interventional study
Exclusion
Key Trial Info
Start Date :
June 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2024
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT05411991
Start Date
June 12 2022
End Date
July 1 2024
Last Update
August 8 2025
Active Locations (2)
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1
University Hospital Brussels
Jette, Brussels Capital, Belgium, 1090
2
Jessa Hospital
Hasselt, Limburg, Belgium, 3500