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

PHASE3RecruitingINTERVENTIONAL
Enrollment

250

Participants

Timeline

Start Date

January 14, 2023

Primary Completion Date

December 1, 2025

Study Completion Date

December 11, 2026

Conditions
Diuretics Drug ReactionsHeart Failure; With DecompensationAlbumin; Double
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.

Trial Locations (1)

68100

RECRUITING

DUThrace Cardiology Department, Alexandroupoli

All Listed Sponsors
lead

Democritus University of Thrace

OTHER