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

Democritus University of Thrace

Status and phase: Enrolling; Phase 3

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

Treatments: Drug: Human albumin

Study type: Interventional

Funder types: Other

Identifiers

NCT06630923

6/ 29.2.2016

Details and patient eligibility

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.

Full 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

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups, including a placebo group

IV Human Albumin + IV Furosemide

Active Comparator group

Description:

Continuous slow IV infusion of Human Albumin plus IV Furosemide

Treatment:

Drug: Human albumin

IV Furosemide alone

Placebo Comparator group

Description:

Continuous slow IV infusion of Furosemide

Treatment:

Drug: Human albumin