Using intravenous albumin to prevent worsening kidney function in heart failure patients
HUMAN ALBUMIN IN HEART FAILURE - DIORASIS TRIAL
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 |
| Enrollment | 250 (estimated) |
| Ages | 18 Years to 95 Years |
| Sex | All |
| Sponsor | Democritus University of Thrace Academic / other |
| Locations | 1 site (Alexandroupoli, Evros) |
| Trial ID | NCT06630923 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years with acute decompensation of CHF and evidence of hepatic dysfunction.
Not a fit: Patients experiencing hemodynamic collapse or severe anemia, among other exclusion criteria, may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Alexandroupoli, Evros
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.