Eosinophil Indices in Patients With Acute Heart Failure

Acute Heart Failure Clinical Trial

Official title:

Predictive Value of Eosinophil Indices for Major Cardiovascular Events in Patients With Acute Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05410990
• Other study ID #: 05062015
• Status: Completed
• Start date: January 2, 2017
• Est. completion date: April 5, 2022

Study information

• Verified date: June 2022
• Source: Giresun University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

All consecutive patients admitted to the intensive care unit (ICU) with ADHF between January 2017 and December 2021 were enrolled in this retrospective study. All-cause mortality and MACE were assessed with respect to relationships with eosinophil indices, including neutrophil-to-eosinophil ratio (NER), leukocyte-to-eosinophil ratio (LER), eosinophil-to-lymphocyte ratio (ELR), and eosinophil-to-monocyte ratio (EMR).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 395
• Est. completion date: April 5, 2022
• Est. primary completion date: December 30, 2021
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Heart Failure
• Heart Failure

Intervention

Diagnostic Test:
• eosinophil and other hematological parameters

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Giresun University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality	all-cause mortality	within the first 6 months of index hospitalization
Secondary	MACE	major adverse cardiovascular events	within the first 6 months of index hospitalization