NCT07085793

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 25, 2025

Completed
Last Updated

August 6, 2025

Status Verified

August 1, 2025

Enrollment Period

5 years

First QC Date

July 17, 2025

Last Update Submit

August 1, 2025

Conditions

Acute Heart Failure

Keywords

Estimated plasma volume status (ePVS)

Outcome Measures

Primary Outcomes (2)

  • readmission for AHF and/or all-cause mortality

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

    30 days

  • readmission for AHF and/or all-cause mortality

    readmission for AHF and/or all-cause mortality

    365 days

Study Arms (1)

1

1

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with acute heart failure admetted in emergency department

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emergency Department

Monastir, 5020, Tunisia

Location

Study Officials

  • Semir Nouira, Pr

    University of Monastir

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
365 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 17, 2025

First Posted

July 25, 2025

Study Start

January 1, 2019

Primary Completion

December 30, 2023

Study Completion

December 30, 2023

Last Updated

August 6, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)