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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03806972
Recruitment Status : Recruiting
First Posted : January 16, 2019
Last Update Posted : February 7, 2019
Sponsor:
Information provided by (Responsible Party):
Pr. Semir Nouira, University of Monastir

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

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1887 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
Estimated Primary Completion Date : January 30, 2019
Estimated Study Completion Date : January 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure




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



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.


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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 <40% or preserved ejection fraction (HFpEF) defined as LVEF ≥55% ,admitted to the ED of Monastir between 2009-2016 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.


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


Contacts
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Contact: Nouira Semir, Professor 73106000 ext 216 semir.nouira@rns.tn
Contact: Bel haj Ali Khaoula, MD 29777277 ext 216 belhajalikhaoula@yahoo.fr

Locations
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Tunisia
Emergency Departement Recruiting
Monastir, Tunisia, 5000
Contact: Semir Nouira, professor    73 106 085 ext 216    semir.nouira@rns.tn   
Contact: Bel Haj Ali Khaoula, MD    29777277 ext 216    belhajalikhaoula@yahoo.fr   
Principal Investigator: semir nouira, professor         
Sponsors and Collaborators
University of Monastir
Investigators
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Principal Investigator: Nouira Semir, Professor university Hospital of Monastir

Additional Information:

Publications:
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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: February 7, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Heart Failure
Heart Diseases
Cardiovascular Diseases