Actively Recruiting

Phase 3
Age: 18Years - 95Years
All Genders
NCT06630923

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

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

250

Participants Needed

1

Research Sites

203 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official 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
  • Acute worsening of chronic heart failure
  • Liver dysfunction confirmed by lab tests or liver ultrasound
  • History of chronic heart failure with prior use of oral loop diuretics
  • Expected need for intravenous diuretic therapy for at least 72 hours
Not Eligible

You will not qualify if you...

  • Hemodynamic collapse defined by very low blood pressure or need for heart support medications (except digoxin)
  • Liver dysfunction caused by conditions other than heart failure
  • Severe anemia with hemoglobin less than 8 g/dL
  • Uncontrolled high blood pressure or hypertensive emergency
  • Pulmonary edema or congestion requiring intravenous vasodilators
  • Serum creatinine over 3 mg/dL or kidney filtration rate less than 30 ml/min

AI-Screening

AI-Powered Screening

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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

CONTACT

A

ANARGYROS TSALGKIDIS

CONTACT

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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