Acute Heart FailureNCT05410990
Eosinophil Indices in Patients With Acute Heart Failure
An observational study of Acute Heart Failure and Reduced Systolic Function, run by Giresun University.
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)… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Heart Failure, Reduced Systolic Function
- What is being tested?
- eosinophil and other hematological parameters
- How many people
- 395 participants
- Where
- No sites listed yet
- Study dates
- 2 Jan 2017to 5 Apr 2022
- How long will I take part?
- 4 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Adult, Older adult
Study population: Acute decompensated heart failure
Who may be able to join
- patients who admitted to the intensive care unit (ICU) with Acute Decompensated Heart Failure and reduced Ejection Fraction (<%40)
Who cannot join
- 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
About this study
Official title: Predictive Value of Eosinophil Indices for Major Cardiovascular Events in Patients With Acute Heart Failure
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).
Read the 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.
- Conditions
- Acute Heart Failure, Reduced Systolic Function
- Being tested
- eosinophil and other hematological parameters
- Keywords
- eosinophil indices, acute heart failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eosinophil and other hematological parametersDiagnostic test
| Study group | Role | What they receive |
|---|---|---|
| mortality, MACE (+) | patients with all-cause mortality within the first 6 months of index hospitalization and MACE (major adverse cardiovascular events) Receives: 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) Receives: Diagnostic Test: eosinophil and other hematological parameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
all-cause mortality
Measured: within the first 6 months of index hospitalization
Secondary outcomes (1)
MACE
major adverse cardiovascular events
Measured: within the first 6 months of index hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start2 Jan 2017
- Primary completion30 Dec 2021
- Study completion5 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 395 participants (actual)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Giresun University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05410990
- Sponsor's protocol ID
- 05062015
- Status last verified
- Jun 2022
- First submitted
- 6 Jun 2022
- Last updated
- 8 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Eosinophil Indices for Major Cardiovascular Events in Patients With Acute Heart Failure
- ClinicalTrials.gov ID
- NCT05410990
- Acronym / sponsor ID
- 05062015
- Conditions
- Acute Heart Failure, Reduced Systolic Function
- Keywords
- eosinophil indices, acute heart failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 395 participants (actual)
- Lead sponsor
- Giresun UniversityUniversity, hospital or other
- Study start
- 2 Jan 2017 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 5 Apr 2022 (actual)
- First posted
- 8 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 4 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mortality, MACE (+) | – | Diagnostic Test: eosinophil and other hematological parameterspatients with all-cause mortality within the first 6 months of index hospitalization and MACE (major adverse cardiovascular events) |
| mortality, MACE (-) | – | Diagnostic Test: eosinophil and other hematological parameterspatients without all-cause mortality within the first 6 months of index hospitalization and MACE (major adverse cardiovascular events) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Acute decompensated heart failure
Key inclusion criteria (1 listed)
- patients who admitted to the intensive care unit (ICU) with Acute Decompensated Heart Failure and reduced Ejection Fraction (<%40)
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eosinophil and other hematological parameters | Diagnostic test | mortality, MACE (+), mortality, MACE (-) |
Primary outcome
mortality
Time frame: within the first 6 months of index hospitalization
all-cause mortality
1 secondary outcome
MACE
Time frame: within the first 6 months of index hospitalization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Heart Failure and Reduced Systolic Function, run by Giresun University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: within the first 6 months of index hospitalization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2022.