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

Phase 3RecruitingNCT06630923

Democritus University of Thrace250 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

250

Conditions

Diuretics Drug Reactions Heart Failure; With Decompensation

Interventions

Human albuminDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 95 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: From baseline to 72 hours.

Change in the serum creatinine level

Time frame: From baseline to 72 hours.

Secondary Outcomes

Patient-reported dyspnea

Patient-reported dyspnea (as assessed with the use of a VAS and quantified as the AUC of serial assessments)

Time frame: From baseline to 72 hours.

Changes in body weight

Time frame: From baseline to 72 hours.

Length of stay

Time frame: From baseline to discharge.

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

Time frame: From baseline to 180 days from discharge.

Net fluid loss

Time frame: From baseline to 72 hours

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts