NCT05410990

Brief 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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
395

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2017

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 8, 2022

Completed
Last Updated

June 8, 2022

Status Verified

June 1, 2022

Enrollment Period

5 years

First QC Date

June 6, 2022

Last Update Submit

June 6, 2022

Conditions

Acute Heart FailureReduced Systolic Function

Keywords

eosinophil indices, acute heart failure

Outcome Measures

Primary Outcomes (1)

  • mortality

    all-cause mortality

    within the first 6 months of index hospitalization

Secondary Outcomes (1)

  • MACE

    within the first 6 months of index hospitalization

Study Arms (2)

mortality, MACE (+)

patients with all-cause mortality within the first 6 months of index hospitalization and MACE (major adverse cardiovascular events)

Diagnostic Test: eosinophil and other hematological parameters

mortality, MACE (-)

patients without all-cause mortality within the first 6 months of index hospitalization and MACE (major adverse cardiovascular events)

Diagnostic Test: eosinophil and other hematological parameters

Interventions

eosinophil and other hematological parametersDIAGNOSTIC_TEST
mortality, MACE (+)mortality, MACE (-)

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Acute decompensated heart failure

You may qualify if:

  • patients who admitted to the intensive care unit (ICU) with Acute Decompensated Heart Failure and reduced Ejection Fraction (\<%40)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
4 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2022

First Posted

June 8, 2022

Study Start

January 2, 2017

Primary Completion

December 30, 2021

Study Completion

April 5, 2022

Last Updated

June 8, 2022

Record last verified: 2022-06