Tests intravenous albumin with water pills in heart failure patients
Tests albumin given with diuretics in adults hospitalized with heart failure.
Plain-language title generated from the registry record
Registry title: PREVENTION OF WORSENING RENAL FUNCTION OF INTRAVENUS ALBUMIN IN HEART FAILURE PATIENTS
Key facts
- Where
- Alexandroupoli, GreeceSee the site
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 95 years old?
Source: NCT06630923, who can take part
Where in Greece
- DUThrace Cardiology DepartmentAlexandroupoli, GreeceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Democritus University of Thrace
- Trial code
- NCT06630923
- Record updated
- 8 October 2024
- Original description
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.Read full original descriptionShow less
HUMAN ALBUMIN IN HEART FAILURE - DIORASIS TRIAL
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.
Inclusion: 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: hepatic dysfunction of other than cardiac etiology; uncontrolled hypertension or hypertensive emergency/urgency; severe anemia (Hb<8 g/dL); serum creatinine > 3 mg/dL or glomerular filtration rate (GFR) < 30 ml/min; 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); pulmonary edema or pulmonary congestion necessitating use of IV vasodilators.