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RECRUITING
NCT06630923
PHASE3

PREVENTION OF WORSENING RENAL FUNCTION OF INTRAVENUS ALBUMIN IN HEART FAILURE PATIENTS

Sponsor: Democritus University of Thrace

View on ClinicalTrials.gov

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.

Official title: HUMAN ALBUMIN IN HEART FAILURE - DIORASIS TRIAL

Key Details

Gender

All

Age Range

18 Years - 95 Years

Study Type

INTERVENTIONAL

Enrollment

250

Start Date

2023-01-14

Completion Date

2026-12-11

Last Updated

2024-10-08

Healthy Volunteers

No

Interventions

DRUG

Human albumin

Experimental intervention (Group A): Continuous slow IV infusion of Human Albumin, based on diuresis-adjusted dosing, not later than 30 minutes after randomisation and not later than 2 hours after admission. Concomitant continuous slow IV infusion of diuretics (furosemide) based on body weight- and diuresis-adjusted dosing. Control intervention (Group B): Continuous slow IV infusion of diuretics (furosemide), based on body weight - and diuresis-adjusted dosing. Experimental intervention (Human Albumin) is off-label treatment for patients with acute decompensation of CHF in Greece. Control intervention (IV diuretic therapy) is on-label treatment for acute decompensation CHF in Greece.

Locations (1)

DUThrace Cardiology Department

Alexandroupoli, Evros, Greece