Pragmatic Urinary Sodium-based Treatment algoritHm in Acute Heart Failure

Not Applicable

Completed

Brief 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.

Detailed Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Natriuresis guided treatment	Natriuresis	-

Primary Outcome Measures

Name	Time	Method
Total Natriuresis After 24 Hours	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).
First Occurrence of All-cause Mortality or Heart Failure Rehospitalization After 180 Days	180 days

Secondary Outcome Measures

Name	Time	Method
48-hours Natriuresis	48 hours	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).
72-hours Natriuresis	72 hours	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).
Length of Hospital Stay	Variable	Number of days of the index hospitalization
Percentage Change in NT-proBNP at 48 Hours	48 hours	Relative NT-proBNP change (%) after 48 hours compared with baseline
Percentage Change in NT-proBNP at 72 Hours	72 hours	Relative NT-proBNP change (%) after 72 hours compared with baseline