Clinical trial NCT06630923: PREVENTION OF WORSENING RENAL FUNCTION OF INTRAVENUS ALBUMIN IN HEART FAILURE PATIENTS
Official title: HUMAN ALBUMIN IN HEART FAILURE - DIORASIS TRIAL
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Diuretics Drug Reactions
Heart Failure; With Decompensation
Albumin; Double
Keywords: Human Albumin
Furosemide
Heart Failure
Lead sponsor: Democritus University of Thrace
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: Assessment of symptoms
timeFrame: From baseline to 72 hours.
measure: Change in the serum creatinine level
timeFrame: From baseline to 72 hours.
Secondary outcomes:
measure: Patient-reported dyspnea
timeFrame: From baseline to 72 hours.
measure: Changes in body weight
timeFrame: From baseline to 72 hours.
measure: Length of stay
timeFrame: From baseline to discharge.
measure: The composite of death, rehospitalization, escalation in treatment or an emergency room visit within 180 days.
timeFrame: From baseline to 180 days from discharge.
measure: Net fluid loss
timeFrame: From baseline to 72 hours
Other outcomes:
Locations:
city: Alexandroupolis
country: Greece
facility: DUThrace Cardiology Department
state: Evros
Study officials:
affiliation: University Hospital of Alexandroupolis
name: MARIOS VASILEIOS KOUTROULOS
role: PRINCIPAL_INVESTIGATOR
References: