Viewing Study NCT07085793


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Study NCT ID: NCT07085793
Status: COMPLETED
Last Update Posted: 2025-08-06
First Post: 2025-07-17
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Estimated Plasma Volume in Patients With Acute Heart Failure
Sponsor: University of Monastir
Organization:

Study Overview

Official Title: Prognostic Value of Estimated Plasma Volume in Patients With Acute Heart Failure
Status: COMPLETED
Status Verified Date: 2025-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: ePVS
Brief Summary: 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.
Detailed Description: 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)

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: