Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2025-12-24 @ 10:06 PM
Study NCT ID:
NCT07263035
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-04
First Post:
2025-11-19
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Urine Sodium-Driven Diuretic Adjustment Strategy in Acute Decompensated Heart Failure
Sponsor:
Lakeland Regional Health Systems, Inc.
Organization:
Study Overview
Official Title:
Urine Sodium-Driven Diuretic Adjustment Strategy in Acute Decompensated Heart Failure
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-11
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:
US-DASH
Brief Summary:
The goal of this clinical trial is to learn if increasing the dose of diuretics to achieve a higher urine sodium target produces better clinical results when treating patients hospitalized with acute heart failure when compared to lower urine sodium target and standard of care.
The main questions it aims to answer are:
1. Does targeting a higher urine sodium goal achieve greater natriuresis and diuresis?
2. Does targeting a higher urine sodium goal reduce frequency of hospital readmissions?
3. Does targeting a higher urine sodium goal reduce hospital length of stay?
Researchers will compare natriuresis-guided arms with standard of care to see if targeting higher natriuresis goals improves significantly over current practice.
Participants will submit urine samples at routine intervals after being given diuretics to evaluate urine sodium concentration. If urine sodium is low then diuretic dose will be increased.
The main questions it aims to answer are:
1. Does targeting a higher urine sodium goal achieve greater natriuresis and diuresis?
2. Does targeting a higher urine sodium goal reduce frequency of hospital readmissions?
3. Does targeting a higher urine sodium goal reduce hospital length of stay?
Researchers will compare natriuresis-guided arms with standard of care to see if targeting higher natriuresis goals improves significantly over current practice.
Participants will submit urine samples at routine intervals after being given diuretics to evaluate urine sodium concentration. If urine sodium is low then diuretic dose will be increased.
Detailed Description:
Patients will be randomized into one of three groups: 50 micromolar natriuresis, 85 micromolar natriuresis, and standard of care. The natriuresis arms will have urine sodium assessed two to four hours administration of intravenous diuretics. If the natriuretic response is inadequate they will immediately receive a higher dose of diuretic. This process will be repeated for the first 72 hours of admission.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: