Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06630923
Status:
RECRUITING
Last Update Posted:
None
First Post:
2023-03-29
Brief Title:
PREVENTION OF WORSENING RENAL FUNCTION OF INTRAVENUS ALBUMIN IN HEART FAILURE PATIENTS
Sponsor:
None
Organization:
None
Study Overview
Official Title:
HUMAN ALBUMIN IN HEART FAILURE - DIORASIS TRIAL
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients hospitalized for acute decompensation of CHF are usually complicated by worsening renal function WRF which leads to diuretic resistance and inadequate decongestion as well as poor prognosis WRF has been attributed to a reflex renal vasoconstriction elicited by intravascular volume depletion during brisk diuresis The investigators hypothesize that CHF patients with hepatic dysfunction are more prone to WRF due to poor albumin production This sub-group of CHF patients may benefit more increased diuretic efficacy and protected against worsening renal function by the use of IV loop diuretics in combination with an intravascular volume expander such as IV Human Albumin
Detailed Description:
Acute decompensation of chronic heart failure CHF warranting hospital admission defined as diagnosed on the basis of the presence of at least one symptom dyspnea orthopnea paroxysmal nocturnal dyspnea weight gain worsening functional class or edema and one sign rales peripheral edema ascites increased jugular vein pressure hepatomegaly third heart sound gallop or pulmonary vascular congestion on chest radiography of heart failure plus laboratory or imaging evidence of hepatic dysfunction at randomization
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None