NCT06630923RecruitingPhase 3
PREVENTION OF WORSENING RENAL FUNCTION OF INTRAVENUS ALBUMIN IN HEART FAILURE PATIENTS
HUMAN ALBUMIN IN HEART FAILURE - DIORASIS TRIAL
Source: ClinicalTrials.gov · Last updated 8 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 250 (estimated)
- First submitted
- 29 Mar 2023
- Start date
- 14 Jan 2023
- Primary completion date
- 1 Dec 2025
- Lead sponsor
- Democritus University of Thrace
- Diseases
- Heart failure
- NCT number
- NCT06630923
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 250
- From 14 Jan 2023 to the primary completion date, 1 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- hepatic dysfunction of other than cardiac etiology
- uncontrolled hypertension or hypertensive emergency/urgency
Lab values
- severe anemia (Hb\<8 g/dL)
- serum creatinine \> 3 mg/dL or glomerular filtration rate (GFR) \< 30 ml/min
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 95 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| DUThrace Cardiology Department Coordinator of this site? Confirm its status | Alexandroupoli | Greece | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.