- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05410990
Eosinophil Indices in Patients With Acute Heart Failure
Predictive Value of Eosinophil Indices for Major Cardiovascular Events in Patients With Acute Heart Failure
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
All consecutive patients admitted to the intensive care unit (ICU) with ADHF and reduced EF between January 2017 and December 2021 were enrolled in this retrospective study. HFrEF was defined as having an LVEF of ≤40%. Demographic data were retrieved from patient charts and the institutional digital database. Patients with an LVEF >40%, NYHA Class I and II subjects, those with advanced liver, kidney diseases or malignancies, patients in whom life expectancy was extremely short and patients with autoimmune, allergic, or infectious diseases that affect the eosinophil indices were not included in the study. The study was approved by the local ethics committee.
Conventional guidelines had been followed for the in-hospital treatment of all patients with ADHF, including loop diuretics, vasodilators, inotropes/vasopressors [9]. Blood tests including complete blood count, blood urea nitrogen and creatinine, electrolytes, liver enzymes, and NT-pro BNP were ordered upon admission to the ICU. All patients underwent transthoracic echocardiography. LVEF was measured with 2-dimensional echocardiography via the modified Simpson method [10]. Data concerning 6-month all-cause mortality and MACE were retrieved from the institutional digital database. The definition of MACE was the composite of total death and re-hospitalization for HF within 6 months of initial hospitalization.
The primary outcome measure of this study was all-cause mortality within the first 6 months of index hospitalization and its relationship with eosinophil indices, including NER, LER, ELR and EMR. The secondary outcome measure of this study was the assessment of MACE within the first 6 months of index hospitalization and its association with eosinophil indices.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- patients who admitted to the intensive care unit (ICU) with Acute Decompensated Heart Failure and reduced Ejection Fraction (<%40)
Exclusion Criteria:
- Patients with an LVEF >40%, NYHA Class I and II subjects, those with advanced liver, kidney diseases or malignancies, patients in whom life expectancy was extremely short and patients with autoimmune, allergic, or infectious diseases
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
mortality, MACE (+)
patients with all-cause mortality within the first 6 months of index hospitalization and MACE (major adverse cardiovascular events)
|
|
mortality, MACE (-)
patients without all-cause mortality within the first 6 months of index hospitalization and MACE (major adverse cardiovascular events)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
mortality
Time Frame: within the first 6 months of index hospitalization
|
all-cause mortality
|
within the first 6 months of index hospitalization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MACE
Time Frame: within the first 6 months of index hospitalization
|
major adverse cardiovascular events
|
within the first 6 months of index hospitalization
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05062015
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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