Ignite Creation Date:
2024-05-06 @ 3:21 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04606927
Status:
COMPLETED
Last Update Posted:
2024-04-22
First Post:
2020-10-18
Brief Title:
Pragmatic Urinary Sodium-based Treatment algoritHm in Acute Heart Failure
Sponsor:
University Medical Center Groningen
Organization:
University Medical Center Groningen
Study Overview
Official Title:
Pragmatic Urinary Sodium-based Treatment algoritHm in Acute Heart Failure
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PUSH-AHF
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 parametersendpoints
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 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 parametersendpoints
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None