Predictors of an Unfavorable Outcome in Patients With Heart Failure
December 17, 2021 updated by: Polish Mother Memorial Hospital Research Institute
Predictors of an Unfavorable Outcome in Patients With Heart Failure With Reduced, Midrange and Preserved Left Ventricular Ejection Fraction
The subject of the study is the factors of unfavorable prognosis in heart failure.
We would like to identify independent variables associated with a bad prognosis of patients hospitalized for heart failure with a reduced vs. a mid range and preserved left ventricular ejection fraction based on specific predictive models.
It is planned to create multifactorial models that can be used to predict prognosis for individual patients.
Study Overview
Detailed Description
About 100 adult patients hospitalized for HF in the Department of Cardiology will be included in the study, including: the study group with HFrEF, HFmrEF and HFpEF.
Selected prognostic factors will be analyzed, among others: demographic data of the patient, physical examination, symptoms, etiology and history of HF, co-morbidities, results of selected laboratory tests, selected electrocardiographic and echocardiographic data, patient's cooperation with the doctor, treatment applied, parameters in the spiroergometric study and distance in 6MWT and subjective assessment of quality of life according to the KCCQ questionnaire.
One year after inclusion in the study, a telephone interview will be conducted with patients.
These will be questions about death, cardiovascular adverse events, hospitalization for heart failure and re-evaluation of the quality of life according to the KCCQ questionnaire.
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Lodz, Poland, 93-338
- Heart Failure Unit; Department of Cardiology and Congenital Diseases of Adults, Polish Mother's Memorial Hospital Research Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age equal to or older than 18 years
- HF (ischemic and non-ischemic) diagnosed according to the 2016 European Society of Cardiology (ESC) guidelines on HF [1], with HF class I, II or III according to the NYHA classification
- current HF hospitalization
- left ventricular ejection fraction (LVEF) documented in echocardiography during the current hospitalization
Exclusion Criteria:
- advanced liver failure (class B and C according to Child-Pugh score
- advanced chronic kidney disease (stages G4 and G5 according to the 2012 Kidney Disease: Improving Global Outcomes (KDIGO) classification
- cerebrovascular accident (transient ischemic attack (TIA) / stroke / intracerebral haemorrhage) within 3 months prior to the hospitalization
- current pregnancy or lactation
- alcohol and drug abuse
- active autoimmune disease
- surgery or a serious injury within 1 months prior to the hospitalization
- other important medical condition that could have shortened the survival time during the study
- impaired cognitive status that compromises the understanding of the steps and completion of the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Identyfication of prognostic factors in HFrEF
Selected prognostic factors will be analyzed in patients with LVEF ≤40%
|
Selected prognostic factors will be analyzed, among others: demographic data of the patient, physical examination, symptoms, etiology and history of HF, co-morbidities, results of selected laboratory tests, selected electrocardiographic and echocardiographic data, patient's cooperation with the doctor, treatment applied, parameters in the spiroergometric study and distance in 6MWT and subjective assessment of quality of life according to the KCCQ questionnaire.
|
|
Other: Identyfication of prognostic factors in HFmrEF
Selected prognostic factors will be analyzed in patients with LVEF 41-49%
|
Selected prognostic factors will be analyzed, among others: demographic data of the patient, physical examination, symptoms, etiology and history of HF, co-morbidities, results of selected laboratory tests, selected electrocardiographic and echocardiographic data, patient's cooperation with the doctor, treatment applied, parameters in the spiroergometric study and distance in 6MWT and subjective assessment of quality of life according to the KCCQ questionnaire.
|
|
Other: Identyfication of prognostic factors in HFpEF
Selected prognostic factors will be analyzed in patients with LVEF ≥50%
|
Selected prognostic factors will be analyzed, among others: demographic data of the patient, physical examination, symptoms, etiology and history of HF, co-morbidities, results of selected laboratory tests, selected electrocardiographic and echocardiographic data, patient's cooperation with the doctor, treatment applied, parameters in the spiroergometric study and distance in 6MWT and subjective assessment of quality of life according to the KCCQ questionnaire.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prognosis in heart failure
Time Frame: One year after inclusion in the study
|
A telephone interview will be conducted with patients.
These will be questions about death, cardiovascular adverse events, hospitalization for heart failure and re-evaluation of the quality of life according to the KCCQ questionnaire.
|
One year after inclusion in the study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2019
Primary Completion (Actual)
February 28, 2020
Study Completion (Actual)
February 28, 2021
Study Registration Dates
First Submitted
February 9, 2021
First Submitted That Met QC Criteria
February 9, 2021
First Posted (Actual)
February 15, 2021
Study Record Updates
Last Update Posted (Actual)
December 20, 2021
Last Update Submitted That Met QC Criteria
December 17, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PMMHRI-BCO.39/2020
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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