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Clinical Trials/NCT04753814
NCT04753814
Completed
Not Applicable

Predictors of an Unfavorable Outcome in Patients With Heart Failure With Reduced, Midrange and Preserved Left Ventricular Ejection Fraction

Polish Mother Memorial Hospital Research Institute1 site in 1 country100 target enrollmentFebruary 1, 2019
ConditionsHeart Failure

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure
Sponsor
Polish Mother Memorial Hospital Research Institute
Enrollment
100
Locations
1
Primary Endpoint
Prognosis in heart failure
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2019
End Date
February 28, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Polish Mother Memorial Hospital Research Institute
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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.

Study Sites (1)

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