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

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving IV albumin (a protein found naturally in blood) to people hospitalized for a flare-up of congestive heart failure (CHF) who also have some degree of liver dysfunction can prevent the kidneys from getting worse during treatment. **You may be eligible if...** - You are over 18 years old - You are hospitalized for acute decompensated heart failure (a CHF flare-up) - You have evidence of liver dysfunction - You have a history of CHF and have been on oral diuretics (water pills) - You are expected to need IV diuretics for at least 72 hours **You may NOT be eligible if...** - You are in hemodynamic collapse (dangerously low blood pressure) - Your liver problems are caused by something other than heart disease - You have severe anemia (very low hemoglobin) - You have severely reduced kidney function (creatinine >3 or GFR <30) - You have uncontrolled high blood pressure or need IV vasodilators Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.