RecruitingPhase 3NCT06630923

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

HUMAN ALBUMIN IN HEART FAILURE - DIORASIS TRIAL

Sponsor

Democritus University of Thrace

Enrollment

250 participants

Start Date

Jan 14, 2023

Study Type

INTERVENTIONAL

Conditions

Heart Failure; With Decompensation Diuretics Drug Reactions Albumin; Double

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

Min Age: 18 YearsMax Age: 95 Years

Inclusion Criteria6

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

Exclusion Criteria6

hemodynamic collapse (at least one of the following: systolic blood pressure (BP) \< 90 mmHg, or BP drop by \>= 40 mmHg for \>= 15 min, with end-organ hypoperfusion; need for inotropes (except of digoxin); need for cardiopulmonary resuscitation).
hepatic dysfunction of other than cardiac etiology
severe anemia (Hb\<8 g/dL)
uncontrolled hypertension or hypertensive emergency/urgency
pulmonary edema or pulmonary congestion necessitating use of IV vasodilators
serum creatinine \> 3 mg/dL or glomerular filtration rate (GFR) \< 30 ml/min

Interventions

DRUGHuman 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.