Phase 4
Completed N=107
Diuretic Treatment in Acute Heart Failure With Volume Overload Guided by Serial Spot Urine Sodium Assessment
Heart Failure · Diuretics Drug Reactions
Source: ClinicalTrials.gov NCT05411991 ↗
Enrolled (actual)
107
Serious AEs
19.4%
Results posted
Aug 2025
Primary outcomePrimary: Mortality, Days in Hospital & Decongestion — 54.68; 44.16 % wins — p=0.357
◆ Published Evidence
Emerging
9citations · ~9 / year
Rationale and Design of the DECONGEST (Diuretic Treatment in Acute Heart Failure With Volume Overload Guided by Serial Spot Urine Sodium Assessment) Study.
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 urine samples after diuretic administration and with low-threshold use of combination diuretic therapy, improves decongestion versus usual care in acute heart failure (AHF), potentially leading to better clinical outcomes.
Linked Publications (2)
-
Rationale and Design of the DECONGEST (Diuretic Treatment in Acute Heart Failure With Volume Overload Guided by Serial Spot Urine Sodium Assessment) Study.
-
Contemporary Diuretic Therapies for Acute Heart Failure: Time for a Desalination-Guided Approach?
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mortality, Days in Hospital & Decongestion |
54.68; 44.16 | 0.357 |
| SECONDARY Renal Safety Endpoint |
9; 3 | — |
| SECONDARY Hemodynamic Safety Endpoint |
10; 4 | — |
| SECONDARY Natriuretic Peptide Change After 30 Days |
-37; -46 | — |
| SECONDARY Cancer Antigen 125 (CA125) Change After 30 Days |
-69; -21 | — |
| SECONDARY Number of Participants With Successful Clinical Decongestion |
33; 26 | — |
| SECONDARY Length of Intravenous Diuretic Therapy |
4; 4 | — |
| SECONDARY Overall Well-being After Decongestion |
0; 0; 3; 0; 3; 4 | — |
| SECONDARY Length of the Index Hospital Admission |
7; 7 | — |
| SECONDARY Number of Participants Who Are Death, or Have a Non-elective Hospital Admission or Non-elective Medical Contact |
9; 12 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05411991) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.