N/A
Completed N=310
Pragmatic Urinary Sodium-based Treatment algoritHm in Acute Heart Failure
Heart Failure Acute
Source: ClinicalTrials.gov NCT04606927 ↗
Enrolled (actual)
310
Serious AEs
41.9%
Results posted
Apr 2024
Primary outcomePrimary: Total Natriuresis After 24 Hours — 409; 345 mmol
Summary
Administration of loop diuretics to achieve decongestion is the current cornerstone of therapy for acute heart failure. Unfortunately, there is a lack of evidence of how to guide diuretic treatment. Recently, urinary sodium, as a response measure of diuretic response, has been proposed as a target for therapy. The hypothesis of this study is that natriuresis guided therapy in patients with acute heart failure will improve diuretic response, decongestion, and reduce length of hospital stay, as well as heart failure rehospitalisations.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Natriuresis After 24 Hours |
409; 345 | — |
| PRIMARY First Occurrence of All-cause Mortality or Heart Failure Rehospitalization After 180 Days |
46; 50 | — |
| SECONDARY 48-hours Natriuresis |
— | — |
| SECONDARY 72-hours Natriuresis |
— | — |
| SECONDARY Length of Hospital Stay |
— | — |
| SECONDARY Percentage Change in NT-proBNP at 48 Hours |
— | — |
| SECONDARY Percentage Change in NT-proBNP at 72 Hours |
— | — |
Eligibility Criteria
Inclusion Criteria
- Male or female ≥ 18 years of age
- Primary diagnosis of acute /decompensated heart failure as assessed by treating physician
a. Acute Heart failure can be de novo or exacerbation of known heart failure and diagnosis is based on criteria in the ESC HF guidelines
- Requirement of intravenous diuretic use
Exclusion Criteria
- Dyspnoea primarily due to non-cardiac causes
- Patients with severe renal impairment receiving dialysis or requiring ultrafiltration
- Inability to follow instructions
- Any other medical conditions that may put the patient at risk or influence study results in the investigator's opinion, or that the investigator deems unsuitable for the study
Data sourced from ClinicalTrials.gov (NCT04606927). 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.