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

NCT06630923 | Recruiting Phase 3

• 1 other identifier: 6/ 29.2.2016
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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

Diuretics Drug Reactions; Heart Failure; With Decompensation; Albumin; Double

Keywords

Human Albumin; Furosemide; Heart Failure

Outcome Measures

Primary Outcomes (2)

• Assessment of symptoms

  Patient's global assessment of symptoms, measured with the use of a visual-analogue scale (VAS) and quantified as the area under the curve (AUC) of serial assessments.

  From baseline to 72 hours.

• Change in the serum creatinine level

  Change in the serum creatinine level

  From baseline to 72 hours.

Secondary Outcomes (5)

• Patient-reported dyspnea

  From baseline to 72 hours.

• Changes in body weight

  From baseline to 72 hours.

• Length of stay

  From baseline to discharge.

• The composite of death, rehospitalization, escalation in treatment or an emergency room visit within 180 days.

  From baseline to 180 days from discharge.

• Net fluid loss

  From baseline to 72 hours

Study Arms (2)

IV Human Albumin + IV Furosemide

ACTIVE COMPARATOR

Continuous slow IV infusion of Human Albumin plus IV Furosemide

Drug: Human albumin

IV Furosemide alone

PLACEBO COMPARATOR

Continuous slow IV infusion of Furosemide

Drug: Human albumin

Interventions

Human albumin DRUG

Experimental intervention (Group A): Continuous slow IV infusion of Human Albumin, based on diuresis-adjusted dosing, not later than 30 minutes after randomisation and not later than 2 hours after admission. Concomitant continuous slow IV infusion of diuretics (furosemide) based on body weight- and diuresis-adjusted dosing. Control intervention (Group B): Continuous slow IV infusion of diuretics (furosemide), based on body weight - and diuresis-adjusted dosing. Experimental intervention (Human Albumin) is off-label treatment for patients with acute decompensation of CHF in Greece. Control intervention (IV diuretic therapy) is on-label treatment for acute decompensation CHF in Greece.

IV Furosemide alone; IV Human Albumin + IV Furosemide

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age over 18 yrs
• acute decompensation of CHF
• evidence of hepatic dysfunction by laboratory biochemical measurements or imaging (liver ultrasonography)
• history of CHF with previous use of an oral loop diuretic
• anticipated need for IV diuretic therapy for at least 72 hours

You may not qualify if:

• 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).
• hepatic dysfunction of other than cardiac etiology
• severe anemia (Hb\<8 g/dL)
• uncontrolled hypertension or hypertensive emergency/urgency
• pulmonary edema or pulmonary congestion necessitating use of IV vasodilators
• serum creatinine \> 3 mg/dL or glomerular filtration rate (GFR) \< 30 ml/min

Sponsors & Collaborators

• Democritus University of Thrace: lead

Study Sites (1)

DUThrace Cardiology Department

Alexandroupoli, Evros, 68100, Greece

RECRUITING

MeSH Terms

Conditions

Heart Failure

Interventions

Serum Albumin, Human

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Serum Albumin; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Blood Proteins

Study Officials

• MARIOS VASILEIOS KOUTROULOS

  University Hospital of Alexandroupolis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MARIOS-VASILEIOS A KOUTROULOS

CONTACT

+30 6942862493; mvkoutroulos@gmail.com

ANARGYROS TSALGKIDIS

CONTACT

6940926983; anargyrost@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiology Resident

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: October 8, 2024
• Study Start: January 14, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 11, 2026
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)