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NCT Number: NCT06630923

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

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.

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Key information

Conditions

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

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

DUThrace Cardiology Department

Alexandroupoli, Evros, 68100, Greece

Location status: Recruiting

Location contact

Marios Vasileios Β Koutroulos

CONTACT

[email protected]

6942862493

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

There is no pre-specified inclusion criterion with respect to ejection fraction

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Assessment of symptoms

    Time frame: From baseline to 72 hours.

    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.

  2. Change in the serum creatinine level

    Time frame: From baseline to 72 hours.

    Change in the serum creatinine level

Secondary outcomes

  1. Patient-reported dyspnea

    Time frame: From baseline to 72 hours.

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

  2. Changes in body weight

    Time frame: From baseline to 72 hours.

    Changes in body weight

  3. Length of stay

    Time frame: From baseline to discharge.

    Length of stay

  4. 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.

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

  5. Net fluid loss

    Time frame: From baseline to 72 hours

    Net fluid loss

Study contacts

Contact information is provided by the study sponsor or research team.

ANARGYROS TSALGKIDIS

CONTACT

[email protected]

6940926983

MARIOS-VASILEIOS A KOUTROULOS

CONTACT

[email protected]

+30 6942862493

Sponsors and collaborators

Lead sponsor

Democritus University of Thrace

Other

Registry information

Official study title

HUMAN ALBUMIN IN HEART FAILURE - DIORASIS TRIAL

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Oct 8, 2024
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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