Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2025-12-27 @ 6:24 AM
Study NCT ID:
NCT06278792
Status:
COMPLETED
Last Update Posted:
2024-02-26
First Post:
2024-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Readily Available Urinary Sodium Analysis in Patients With Acute Decompensated Heart Failure
Sponsor:
Ziekenhuis Oost-Limburg
Organization:
Study Overview
Official Title:
Readily Available Urinary Sodium Analysis in Patients With Acute Decompensated Heart Failure
Status:
COMPLETED
Status Verified Date:
2024-02
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:
EASY-HF
Brief Summary:
The goal of this clinical trial is to compare physician-guided (SOC) versus nurse-led natriuresis-guided diuretic therapy in patients with acute decompensated heart failure (ADHF). The main questions it aims to answer are:
* difference in natriuresis and diuresis
* feasibility of the protocol.
Participants will be asked to gather two 24 h urine collections.
Researchers will compare SOC versus nurse-led diuretic titration to see if there is a difference in natriuresis after 48 hours.
* difference in natriuresis and diuresis
* feasibility of the protocol.
Participants will be asked to gather two 24 h urine collections.
Researchers will compare SOC versus nurse-led diuretic titration to see if there is a difference in natriuresis after 48 hours.
Detailed Description:
The EASY-HF study was a single-centre, randomized, open-label study comparing standard of care (SOC) diuretic management at the treating physician's discretion with a nurse-led natriuresis-guided protocol in patients with ADHF. A bedside sensor was used to measure the urinary sodium content.The primary endpoint was total natriuresis after 48 hours. Secondary endpoints included safety profile and user-friendliness of both the protocol and the point-of-care sensor.
Study Oversight
Has Oversight DMC:
False
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?: