Pragmatic Urinary Sodium-based Treatment algoritHm in Acute Heart Failure

Study Overview
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Brief Summary
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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.

Detailed Description
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Objective: To assess the effect of natriuresis guided therapy in acute heart failure to improve diuretic response, decongestion, and clinical outcomes Study design: Randomised, controlled, open label study Study population: 310 patients admitted with the primary diagnosis of acute heart failure requiring intravenous loop diuretics. Intervention: natriuresis guided treatment versus standard of care Main study parameters/endpoints: Co-primary outcome: total natriuresis after 24 hours, and first occurrence of all-cause mortality or heart failure rehospitalisation at 6 months Secondary outcomes: 48- and 72-hours natriuresis, length of hospital stay, percentage change in NT-proBNP at 48 and 72 hours. Safety endpoint: doubling of serum creatinine at 24 or 48 hours, worsening heart failure.

Official Title
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Pragmatic Urinary Sodium-based Treatment algoritHm in Acute Heart Failure

Conditions
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Heart Failure Acute

Intervention / Treatment
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* Other: Natriuresis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Natriuresis guided treatment<br> | Other: Natriuresis<br>* Patients with insufficient decongestive response based on natriuresis (in the active arm) will be eligible for treatment adjustments according to the natriuresis guided treatment algorithm.<br>|
| No Intervention: Standard of care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total natriuresis after 24 hours | The first component of the co-primary end-point is total natriuresis after 24 h (mmol). To assess this, urine is collected for 24 hours after the first administration of diuretics according to the study protocol and natriuresis is calculated as the total amount of diuresis (L) multiplied by the urinary sodium concentration (mmol/L). | 24 hours | 
| First occurrence of all-cause mortality or heart failure rehospitalization after 180 days |  | 180 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 48-hours natriuresis | 48-hour natriuresis will be assessed by collecting urine for a second period of 24 hours after the first 24-hour urine collection according to the study protocol and natriuresis is calculated as the total amount of diuresis (L) multiplied by the urinary sodium concentration (mmol/L). | 48 hours | 
| 72-hours natriuresis | 72-hour natriuresis will be assessed by collecting urine for a third period of 24 hours after the second 24-hour urine collection according to the study protocol and natriuresis is calculated as the total amount of diuresis (L) multiplied by the urinary sodium concentration (mmol/L). | 72 hours | 
| Length of hospital stay | Number of days of the index hospitalization | Variable | 
| Percentage change in NT-proBNP at 48 hours | Relative NT-proBNP change (%) after 48 hours compared with baseline | 48 hours | 
| Percentage change in NT-proBNP at 72 hours | Relative NT-proBNP change (%) after 72 hours compared with baseline | 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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loop diuretics, natriuresis