Clinical trial NCT04606927: Pragmatic Urinary Sodium-based Treatment algoritHm in Acute Heart Failure
Official title: Pragmatic Urinary Sodium-based Treatment algoritHm in Acute Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure Acute
Keywords: loop diuretics
natriuresis
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2020-10-28
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Male or female ≥ 18 years of age
2. 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
3. Requirement of intravenous diuretic use

Exclusion Criteria:

1. Dyspnoea primarily due to non-cardiac causes
2. Patients with severe renal impairment receiving dialysis or requiring ultrafiltration
3. Inability to follow instructions
4. 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

Primary outcomes:
measure: Total Natriuresis After 24 Hours
timeFrame: 24 hours
measure: First Occurrence of All-cause Mortality or Heart Failure Rehospitalization After 180 Days
timeFrame: 180 days
Secondary outcomes:
measure: 48-hours Natriuresis
timeFrame: 48 hours
measure: 72-hours Natriuresis
timeFrame: 72 hours
measure: Length of Hospital Stay
timeFrame: Variable
measure: Percentage Change in NT-proBNP at 48 Hours
timeFrame: 48 hours
measure: Percentage Change in NT-proBNP at 72 Hours
timeFrame: 72 hours
Other outcomes:
measure: Safety Endpoint: Doubling of Serum Creatinine at 24 Hours
timeFrame: 24 hours
measure: Safety Endpoint: Doubling of Serum Creatinine at 48 Hours
timeFrame: 48 hours
measure: Worsening Heart Failure
timeFrame: During the index hospitalization (variable)
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
References: