PREVENTION OF WORSENING RENAL FUNCTION OF INTRAVENUS ALBUMIN IN HEART FAILURE PATIENTS
Launched by DEMOCRITUS UNIVERSITY OF THRACE · Oct 4, 2024
Trial Information
Current as of July 09, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at a way to help heart failure patients who are experiencing worsening kidney function while being treated in the hospital. When heart failure gets worse, it can lead to problems with kidney function, making it harder for doctors to remove excess fluid from the body. The researchers believe that patients with liver problems might be at higher risk for kidney issues when treated with regular diuretics (medications that help remove fluid). They are testing whether using intravenous (IV) human albumin, along with diuretics, can help these patients recover better and prevent further kidney damage.
To be eligible for the study, participants must be over 18 years old, have acute heart failure, and show signs of liver dysfunction. They also need to have been treated with oral diuretics before and require IV diuretics for at least three days. If someone joins the study, they can expect to receive either the new treatment or standard care while being closely monitored for their heart and kidney functions. This trial is currently recruiting participants, and it’s important for patients to discuss with their healthcare providers if this study might be a good option for them.
Gender
ALL
Eligibility 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
About Democritus University Of Thrace
Democritus University of Thrace is a leading academic institution in Greece, renowned for its commitment to advancing health sciences through innovative research and clinical trials. The university's research initiatives are driven by a multidisciplinary approach, fostering collaboration among experts in medicine, pharmacology, and biotechnology. With a focus on improving patient outcomes and contributing to the global body of medical knowledge, Democritus University of Thrace actively sponsors clinical trials that address critical health challenges, ensuring adherence to the highest ethical and scientific standards. Through its dedication to education and research, the university plays a pivotal role in shaping the future of healthcare.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Alexandroupolis, Evros, Greece
Patients applied
Trial Officials
MARIOS VASILEIOS KOUTROULOS
Principal Investigator
University Hospital of Alexandroupolis
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported