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Completed

NCT Number: NCT07085793

Estimated Plasma Volume in Patients With Acute Heart Failure

Congestion plays an essential role in acute heart failure (AHF) outcomes. Estimated plasma volume status (ePVS), derived from simple hematological parameters, may offer prognostic value.

The objectif is to assess the prognostic value of admission ePVS, calculated using Duarte and Hakim formulas, for short- and long-term mortality and/or readmission in patients hospitalized for AHF.

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Key information

Conditions

Acute Heart Failure

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Emergency Department

Monastir, 5020, Tunisia

About this study

it is a prospective cross-sectional study in the emergency department of Fattouma Bourguiba University Hospital of Monastir, Tunisia.This study was approved by the Institutional Review Boardof our institute and conducted according to the revised Declaration of Helsinki. The requirement of written informed consent was waived, as this study is observational. an opt-out method was used for participant recruitment.

ePVS at admission was calculated as follows:

  • Duarte ePVS= 100-ht(%) /Hb(g/dl).
  • Hakim ePVS = [(actual plasma volume-ideal plasma volume)/ideal plasma volume] × 100 Actual plasma volume: (1-hematocrit) × (a+b×body weight in kg). Ideal plasma volume = c×body weight in kg. (males: a = 1530, b = 41.0, c = 39; females; a = 864, b = 47.9, c = 40)

Who can participate

Healthy volunteers accepted: No

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

  • Inclusiuon criteria :
  • Patients aged over 18
  • diagnosis of AHF based on clinical examination, echocardiography, the value of BNP or NT pro-BNP and expert opinion.
  • Exclusion criteria :
  • pregnancy
  • end-stage or severe renal failure with creatinine clearance < 15 ml/min
  • hemodialysis.
  • refusal to consent
  • Pregnant or breast feeding women.
  • Alteration of consciousness GCS < 15
  • Critically ill patients needing immediate mechanical hemodynamic of ventilatory support.
  • Inability to follow instructions or comply with follow-up procedures.

Treatment and study plan

Primary outcomes

  1. readmission for AHF and/or all-cause mortality

    Time frame: 30 days

    readmission for AHF and/or all-cause mortality at 1 month

  2. readmission for AHF and/or all-cause mortality

    Time frame: 365 days

    readmission for AHF and/or all-cause mortality

Sponsors and collaborators

Lead sponsor

University of Monastir

Other

Registry information

Official study title

Prognostic Value of Estimated Plasma Volume in Patients With Acute Heart Failure

Acronym: ePVS

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jul 25, 2025
Registry last updated
Aug 6, 2025

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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