drugset / Trial / NCT06630923

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

NCT06630923

Phase 3 Recruiting 250 enrolled Democritus University of Thrace
RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start
2023-01-14
Primary completion
2025-12-01
Completion
2026-12-11

Drugs

EvaluationDrugModalityDoseRoute
Comparator Albumin Protein / enzyme biologic Intravenous