Actively Recruiting

Phase 3
Age: 18Years - 95Years
All Genders
ID06630923

Human Albumin in Heart Failure - DIORASIS Trial Evaluating Prevention of Worsening Renal Function with IV Albumin and Furosemide

Led by Democritus University of Thrace · Updated on 2024-10-08

250

Participants Needed

1

Research Sites

53 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This trial focuses on patients hospitalized with acute decompensation of chronic heart failure (CHF), who often experience worsening renal function (WRF) leading to resistance to diuretics and poor outcomes. Researchers are investigating if CHF patients with liver dysfunction, who produce less albumin, are more prone to WRF. The study evaluates whether adding intravenous human albumin to standard IV loop diuretics improves diuretic effectiveness and protects kidney function in these patients. Participants are randomly assigned to receive either a continuous slow intravenous infusion of human albumin combined with IV furosemide or IV furosemide alone. The human albumin infusion is adjusted based on urine output and starts within 30 minutes after randomization and within 2 hours of hospital admission. Both groups receive diuretics adjusted by body weight and urine output. The study treatment lasts for at least 72 hours. During the study, researchers will assess symptoms and changes in serum creatinine levels from baseline to 72 hours. Additional measures include patient-reported breathlessness, body weight changes, fluid loss, length of hospital stay, and a composite outcome of death, rehospitalization, treatment escalation, or emergency visits up to 180 days after discharge. Participants are closely monitored with laboratory and imaging tests to evaluate liver function and kidney status throughout the study period, which is expected to continue until December 2026.

CONDITIONS

Brief Title

PREVENTION OF WORSENING RENAL FUNCTION OF INTRAVENUS ALBUMIN IN HEART FAILURE PATIENTS

Who Can Participate

Age: 18Years - 95Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 18 years and up to 95 years
  • Acute decompensation of chronic heart failure
  • Evidence of hepatic dysfunction by laboratory tests or liver ultrasound
  • History of chronic heart failure with previous use of oral loop diuretics
  • Anticipated need for intravenous diuretic therapy for at least 72 hours
Not Eligible

You will not qualify if you...

  • Hemodynamic collapse including low blood pressure below 90 mmHg or significant blood pressure drop with organ hypoperfusion
  • Need for inotropic drugs except digoxin or cardiopulmonary resuscitation
  • Hepatic dysfunction from causes other than heart failure
  • Severe anemia with hemoglobin less than 8 g/dL
  • Uncontrolled hypertension or hypertensive emergency
  • Pulmonary edema or congestion requiring intravenous vasodilators
  • Serum creatinine over 3 mg/dL or glomerular filtration rate below 30 ml/min

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 72 hours

Participants receive continuous slow IV infusion of Human Albumin plus IV Furosemide or IV Furosemide alone based on their assigned group to manage acute decompensation of chronic heart failure.

Continuous treatment during hospitalization

Follow-up

Duration - Up to 180 days from discharge

Participants are monitored for clinical outcomes including rehospitalization, treatment escalation, emergency visits, and survival after discharge.

Follow-up visits or contacts up to 180 days

Trial Site Locations

Total: 1 location

1

DUThrace Cardiology Department

Alexandroupoli, Evros, Greece, 68100

Actively Recruiting

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Research Team

M

MARIOS-VASILEIOS A KOUTROULOS

A

ANARGYROS TSALGKIDIS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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