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

Status

Completed

Conditions

Intervention / Treatment

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

  • Poland
      • Lodz, Poland, 93-338
        • Heart Failure Unit; Department of Cardiology and Congenital Diseases of Adults, Polish Mother's Memorial Hospital Research Institute

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%
Diagnostic test: Diagostic tests
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%
Diagnostic test: Diagostic tests
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%
Diagnostic test: Diagostic tests
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.

Sponsor

Polish Mother Memorial Hospital Research Institute

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.

General Publications

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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