We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03806972
Recruitment Status : Completed
First Posted : January 16, 2019
Last Update Posted : October 13, 2021
Sponsor:
Information provided by (Responsible Party):
Pr. Semir Nouira, University of Monastir

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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).


Condition or disease
Acute Heart Failure

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 1800 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Short and Long Term Prognosis of Patients Admitted to the Emergency Department With Acute Heart Failure
Actual Study Start Date : June 1, 2009
Actual Primary Completion Date : October 1, 2021
Actual Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Death or readmission rates [ Time Frame: within 365 days after hospital discharge ]
    A composite outcome of Death or readmission within 365 days of hospital discharge


Secondary Outcome Measures :
  1. Death or readmission rates [ Time Frame: within 30 days after hospital discharge ]
    A composite outcome of Death or readmission within 30 days of hospital discharge


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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 between 2009-2020 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 .
Criteria

Inclusion Criteria:

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

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.

Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03806972


Locations
Layout table for location information
Tunisia
Emergency Departement
Monastir, Tunisia, 5000
Sponsors and Collaborators
University of Monastir
Investigators
Layout table for investigator information
Principal Investigator: Nouira Semir, Professor university Hospital of Monastir
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications:

Layout table for additonal information
Responsible Party: Pr. Semir Nouira, professor, University of Monastir
ClinicalTrials.gov Identifier: NCT03806972    
Other Study ID Numbers: CRF
First Posted: January 16, 2019    Key Record Dates
Last Update Posted: October 13, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pr. Semir Nouira, University of Monastir:
acute heart failure prognosis
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Heart Diseases
Cardiovascular Diseases