PREVENTION OF WORSENING RENAL FUNCTION OF INTRAVENUS ALBUMIN IN HEART FAILURE PATIENTS
Recruiting now · Phase 3
Conditions studied: Diuretics Drug Reactions, Heart Failure; With Decompensation, Albumin; Double
In brief
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.
Key facts
- Study ID
- NCT06630923
- Run by
- Democritus University of Thrace
- People needed
- 250
- Starts
- 2023-01-14
- Expected to finish
- 2026-12-11
- Last updated by the study team
- 2024-10-08
Who can join
Age: 18 and older, up to 95. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- DUThrace Cardiology Department — Alexandroupoli, Evros, Greece (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.