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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
310
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.
University Medical Center Groningen
Groningen, Netherlands
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).
Time frame: 24 hours
First Occurrence of All-cause Mortality or Heart Failure Rehospitalization After 180 Days
Time frame: 180 days
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).
Time frame: 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).
Time frame: 72 hours
Length of Hospital Stay
Number of days of the index hospitalization
Time frame: Variable
Percentage Change in NT-proBNP at 48 Hours
Relative NT-proBNP change (%) after 48 hours compared with baseline
Time frame: 48 hours
Percentage Change in NT-proBNP at 72 Hours
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Relative NT-proBNP change (%) after 72 hours compared with baseline
Time frame: 72 hours