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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03806972
Other study ID # CRF
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2009
Est. completion date October 1, 2021

Study information

Verified date October 2021
Source University of Monastir
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 1800
Est. completion date October 1, 2021
Est. primary completion date October 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Tunisia Emergency Departement Monastir

Sponsors (1)

Lead Sponsor Collaborator
University of Monastir

Country where clinical trial is conducted

Tunisia, 

References & 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. — View Citation

Searle J, Frick J, Möckel M. Acute heart failure facts and numbers: acute heart failure populations. ESC Heart Fail. 2016 Jun;3(2):65-70. Epub 2016 Apr 25. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Death or readmission rates A composite outcome of Death or readmission within 365 days of hospital discharge within 365 days after hospital discharge
Secondary Death or readmission rates A composite outcome of Death or readmission within 30 days of hospital discharge within 30 days after hospital discharge
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