NCT03806972

Brief 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).

Trial Health

77
On Track

Trial Health Score

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

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
56mo left

Started Jun 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress79%
Jun 2009Dec 2030

Study Start

First participant enrolled

June 1, 2009

Completed
9.6 years until next milestone

First Submitted

Initial submission to the registry

January 15, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 16, 2019

Completed
11.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

July 22, 2025

Status Verified

July 1, 2025

Enrollment Period

21.5 years

First QC Date

January 15, 2019

Last Update Submit

July 17, 2025

Conditions

Keywords

acute heart failure prognosis

Outcome Measures

Primary Outcomes (1)

  • Death or readmission rates

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

    within 365 days after hospital discharge

Secondary Outcomes (1)

  • Death or readmission rates

    within 30 days after hospital discharge

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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 .

You may qualify if:

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

You may not qualify if:

  • 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 Departement

Monastir, Monastir Governorate, 5000, Tunisia

RECRUITING

Related Publications (2)

  • 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.

    PMID: 28682895BACKGROUND
  • 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.

    PMID: 27818780BACKGROUND

Study Officials

  • Nouira Semir, Professor

    university Hospital of Monastir

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nouira Semir, Professor

CONTACT

Bel haj Ali Khaoula, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

January 15, 2019

First Posted

January 16, 2019

Study Start

June 1, 2009

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Last Updated

July 22, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations