NCT04606927

Pragmatic Urinary Sodium-based Treatment algoritHm in Acute Heart Failure

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 310 (actual)
• Sponsor: University Medical Center Groningen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure Acute

Interventions

Type	Name	Description
OTHER	Natriuresis	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.

Timeline

• Start date: 2021-02-01
• Primary completion: 2023-05-09
• Completion: 2023-06-01
• First posted: 2020-10-28
• Last updated: 2024-04-22
• Results posted: 2024-04-22

Locations

1 site across 1 country: Netherlands