Predictors of an Unfavorable Outcome in Patients With Heart Failure
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Diagostic tests
Sponsored by

About this trial
This is an interventional supportive care trial for Heart Failure
Eligibility Criteria
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
Sites / Locations
- Heart Failure Unit; Department of Cardiology and Congenital Diseases of Adults, Polish Mother's Memorial Hospital Research Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Identyfication of prognostic factors in HFrEF
Identyfication of prognostic factors in HFmrEF
Identyfication of prognostic factors in HFpEF
Arm Description
Selected prognostic factors will be analyzed in patients with LVEF ≤40%
Selected prognostic factors will be analyzed in patients with LVEF 41-49%
Selected prognostic factors will be analyzed in patients with LVEF ≥50%
Outcomes
Primary Outcome Measures
Prognosis in heart failure
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04753814
First Posted
February 9, 2021
Last Updated
December 17, 2021
Sponsor
Polish Mother Memorial Hospital Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT04753814
Brief Title
Predictors of an Unfavorable Outcome in Patients With Heart Failure
Official Title
Predictors of an Unfavorable Outcome in Patients With Heart Failure With Reduced, Midrange and Preserved Left Ventricular Ejection Fraction
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
February 28, 2020 (Actual)
Study Completion Date
February 28, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Polish Mother Memorial Hospital Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model 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, with HFmrEF and with HFpEF
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Identyfication of prognostic factors in HFrEF
Arm Type
Other
Arm Description
Selected prognostic factors will be analyzed in patients with LVEF ≤40%
Arm Title
Identyfication of prognostic factors in HFmrEF
Arm Type
Other
Arm Description
Selected prognostic factors will be analyzed in patients with LVEF 41-49%
Arm Title
Identyfication of prognostic factors in HFpEF
Arm Type
Other
Arm Description
Selected prognostic factors will be analyzed in patients with LVEF ≥50%
Intervention Type
Diagnostic Test
Intervention Name(s)
Diagostic tests
Intervention Description
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.
Primary Outcome Measure Information:
Title
Prognosis in heart failure
Description
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.
Time Frame
One year after inclusion in the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agata Bielecka-Dabrowa
Organizational Affiliation
Heart Failure Unit; Department of Cardiology and Congenital Diseases of Adults, PMMHRI
Official's Role
Study Chair
Facility Information:
Facility Name
Heart Failure Unit; Department of Cardiology and Congenital Diseases of Adults, Polish Mother's Memorial Hospital Research Institute
City
Lodz
ZIP/Postal Code
93-338
Country
Poland
12. IPD Sharing Statement
Citations:
PubMed Identifier
27206819
Citation
Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; ESC Scientific Document Group. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. No abstract available. Erratum In: Eur Heart J. 2016 Dec 30;:
Results Reference
result
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Predictors of an Unfavorable Outcome in Patients With Heart Failure
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