Using intravenous albumin to prevent worsening kidney function in heart failure patients
Official title: HUMAN ALBUMIN IN HEART FAILURE - DIORASIS TRIAL
Run by Democritus University of Thrace · NCT06630923 · Data updated 2026-11-12
This study is testing if giving heart failure patients a special protein through an IV can help their kidneys work better when they're also having liver problems.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 95 Years |
| Sex | All |
| Enrollment | 250 (estimated) |
| Sponsor | Democritus University of Thrace Academic / other |
| Locations | 1 site (Alexandroupoli, Evros) |
| Status | Recruiting |
| Started | January 14, 2023 |
| Main results expected | December 1, 2025 |
| Study ends | December 11, 2026 |
| Registry record updated | October 8, 2024 |
| Trial ID | NCT06630923 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 years with acute decompensation of CHF and evidence of hepatic dysfunction.
✕Probably not a fit
Patients experiencing hemodynamic collapse or severe anemia, among other exclusion criteria, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the use of intravenous human albumin in patients hospitalized for acute decompensation of chronic heart failure (CHF) who also exhibit signs of hepatic dysfunction. The study aims to determine if combining albumin with loop diuretics can improve diuretic efficacy and protect against worsening renal function, which is a common complication in these patients. Participants will be monitored for their response to treatment over a period of at least 72 hours. The trial focuses on a specific subgroup of CHF patients who may be particularly vulnerable to renal issues due to their liver condition.
Why it matters
Potential benefit: If successful, this approach could enhance diuretic effectiveness and safeguard kidney function in heart failure patients with liver dysfunction.
How similar studies have gone: While the specific combination of intravenous albumin and diuretics in this context is novel, similar approaches have shown promise in managing renal function in heart failure patients.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. age over 18 yrs 2. acute decompensation of CHF 3. evidence of hepatic dysfunction by laboratory biochemical measurements or imaging (liver ultrasonography) 4. history of CHF with previous use of an oral loop diuretic 5. anticipated need for IV diuretic therapy for at least 72 hours There is no pre-specified inclusion criterion with respect to ejection fraction Exclusion Criteria: 1. 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). 2. hepatic dysfunction of other than cardiac etiology 3. severe anemia (Hb\<8 g/dL) 4. uncontrolled hypertension or hypertensive emergency/urgency 5. pulmonary edema or pulmonary congestion necessitating use of IV vasodilators 6. serum creatinine \> 3 mg/dL or glomerular filtration rate (GFR) \< 30 ml/min
Where it's running
-
DUThrace Cardiology Department
Alexandroupoli, Evros, Greece Recruiting
Study contacts
- Principal investigator: Marios Vasileios Koutroulos — University Hospital of Alexandroupolis
- Study coordinator: Marios-Vasileios a Koutroulos
- Email: mvkoutroulos@gmail.com
- Phone: +30 6942862493
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.