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RecruitingNCT03806972CRFUpdated Jul 22, 2025

Short and Long Term Prognosis of Patients Admitted to the ED With Acute Heart Failure

An observational study in Acute Heart Failure, sponsored by University of Monastir. Recruiting at 1 site in Tunisia. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-07-22.

Sponsored by University of Monastir · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
3,000
Ages
18 Years to 80 Years
Sex
All
01

Study summary

Heart failure (HF) is the leading cause of hospitalization ,rehospitalization and mortality for adults over 65 years of age.

This study aimed to assess mortality, and hospitalization rates at 30 days and one year after dicharge of patients with heart failure (HF) with reduced ejection fraction (HFrEF) compared to HF with preserved ejection fraction (HFpEF).

02

Conditions studied

  • Acute Heart Failure

Keywords

  • acute heart failure prognosis
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

This study included all patients ,with either reduced ejection fraction (HFrEF) defined as LVEF \<45% or preserved ejection fraction (HFpEF) defined as LVEF ≥45% ,admitted to the ED of Monastir from 2009 with a principal discharge diagnosis code for HF. The diagnosis of HF categories should rely on the recent transthoracic echocardiographic findings and clinical judgement according to the guidelines.Collected data include clinical features biological markers (BNP or NTpro BNP) and echocardiography findings. The diagnosis of HF categories should rely on the recent transthoracic echocardiographic findings and clinical judgement according to the guidelines. A follow-up period of at least 1 year was required to notice all cause mortality and preferably HF-specific rehospitalization .

Inclusion criteria

  • patients admitted to the ED of Monastir with a principal discharge diagnosis code for HF.

Exclusion criteria

Exclusion Criteria:

  • 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.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
3,000 participants (estimated)
Target follow-up
12 Months
Patient registry
Yes
05

What researchers measure

Primary outcomes

  1. Death or readmission rates

    A composite outcome of Death or readmission within 365 days of hospital discharge

    Time frame: within 365 days after hospital discharge

Secondary outcomes

  1. Death or readmission rates

    A composite outcome of Death or readmission within 30 days of hospital discharge

    Time frame: within 30 days after hospital discharge

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Study locations

1 of 1 sites recruiting
  • Emergency Departement
    Monastir, Monastir Governorate 5000, Tunisia
    Recruiting
07

References and documents

Publications

  • Castello LM, Molinari L, Renghi A, Peruzzi E, Capponi A, Avanzi GC, Pirisi M. Acute decompensated heart failure in the emergency department: Identification of early predictors of outcome. Medicine (Baltimore). 2017 Jul;96(27):e7401. doi: 10.1097/MD.0000000000007401. PubMed 28682895 ↗
  • Searle J, Frick J, Mockel M. Acute heart failure facts and numbers: acute heart failure populations. ESC Heart Fail. 2016 Jun;3(2):65-70. doi: 10.1002/ehf2.12092. Epub 2016 Apr 25. PubMed 27818780 ↗

Individual participant data

Plan to share: No

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Registry details

Key details

Study ID
NCT03806972
Lead sponsor
University of Monastir
Responsible party
Pr. Semir Nouira (professor, University of Monastir) — Principal investigator
First posted
Jan 16, 2019
Start date
Jun 1, 2009
Primary completion
Dec 1, 2030 (estimated)
Completion
Dec 1, 2030 (estimated)
Last update
Jul 22, 2025

Study contacts

Nouira Semir, Professor
Contact
semir.nouira@rns.tn
73106000 ext. 216
Bel haj Ali Khaoula, MD
Contact
belhajalikhaoula@yahoo.fr
29777277 ext. 216
Nouira Semir, Professor
principal investigator · university Hospital of Monastir

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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