Short and Long Term Prognosis of Patients Admitted to the ED With Acute Heart Failure (CRF)
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| ClinicalTrials.gov Identifier: NCT03806972 |
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Recruitment Status :
Recruiting
First Posted : January 16, 2019
Last Update Posted : February 7, 2019
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Sponsor:
University of Monastir
Information provided by (Responsible Party):
Pr. Semir Nouira, University of Monastir
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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 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 :
- 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 :
- 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
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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
| Contact: Nouira Semir, Professor | 73106000 ext 216 | semir.nouira@rns.tn | |
| Contact: Bel haj Ali Khaoula, MD | 29777277 ext 216 | belhajalikhaoula@yahoo.fr |
Locations
| 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
| Principal Investigator: | Nouira Semir, Professor | university Hospital of Monastir |
Additional Information:
Publications:
| 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 |
| 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:
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acute heart failure prognosis |
Additional relevant MeSH terms:
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Heart Failure Heart Diseases Cardiovascular Diseases |