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

NCT ID: NCT06630923

Last Updated: 2024-10-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-14
• Study Completion Date: 2026-12-11

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.

Detailed Description

Acute decompensation of chronic heart failure (CHF) warranting hospital admission, defined as diagnosed on the basis of the presence of at least one symptom (dyspnea, orthopnea, paroxysmal nocturnal dyspnea, weight gain, worsening functional class or edema) and one sign (rales, peripheral edema, ascites, increased jugular vein pressure, hepatomegaly, third heart sound gallop or pulmonary vascular congestion on chest radiography) of heart failure plus laboratory or imaging evidence of hepatic dysfunction at randomization

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

IV Human Albumin + IV Furosemide

Continuous slow IV infusion of Human Albumin plus IV Furosemide

Group Type: ACTIVE_COMPARATOR

Human albumin

Intervention Type: 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

Continuous slow IV infusion of Furosemide

Group Type: PLACEBO_COMPARATOR

Human albumin

Intervention Type: 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.

Interventions

Human albumin

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Democritus University of Thrace

OTHER

Sponsor Role: lead

Responsible Party

Marios-Vasileios Koutroulos

Cardiology Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

MARIOS VASILEIOS KOUTROULOS

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Alexandroupolis

Locations

DUThrace Cardiology Department

Alexandroupoli, Evros, Greece

Site Status: RECRUITING

Countries

Greece

Central Contacts

MARIOS-VASILEIOS A KOUTROULOS

Role: CONTACT

mvkoutroulos@gmail.com

+30 6942862493

ANARGYROS TSALGKIDIS

Role: CONTACT

anargyrost@gmail.com

6940926983

Facility Contacts

Marios Vasileios Β Koutroulos

Role: primary

mvkoutroulos@gmail.com

6942862493

Other Identifiers

6/ 29.2.2016

Identifier Type: -

Identifier Source: org_study_id