HUMAN ALBUMIN IN HEART FAILURE - DIORASIS TRIAL

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 95
Healthy Volunteers: f
View:

• age over 18 yrs

• acute decompensation of CHF

• evidence of hepatic dysfunction by laboratory biochemical measurements or imaging (liver ultrasonography)

• history of CHF with previous use of an oral loop diuretic

• anticipated need for IV diuretic therapy for at least 72 hours

⁃ There is no pre-specified inclusion criterion with respect to ejection fraction

Locations
Other Locations
Greece
DUThrace Cardiology Department
RECRUITING
Alexandroupoli
Contact Information
Primary
MARIOS-VASILEIOS A KOUTROULOS
mvkoutroulos@gmail.com
+30 6942862493
Backup
ANARGYROS TSALGKIDIS
anargyrost@gmail.com
6940926983
Time Frame
Start Date: 2023-01-14
Estimated Completion Date: 2026-12-11
Participants
Target number of participants: 250
Treatments
Active_comparator: IV Human Albumin + IV Furosemide
Continuous slow IV infusion of Human Albumin plus IV Furosemide
Placebo_comparator: IV Furosemide alone
Continuous slow IV infusion of Furosemide
Related Therapeutic Areas
Sponsors
Leads: Democritus University of Thrace

This content was sourced from clinicaltrials.gov

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