Predictors of an Unfavorable Outcome in Patients With Heart Failure

Polish Mother Memorial Hospital Research Institute

Status: Completed

Conditions: Heart Failure

Treatments: Diagnostic Test: Diagostic tests

Study type: Interventional

Funder types: Other

Identifiers

NCT04753814

PMMHRI-BCO.39/2020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

Identyfication of prognostic factors in HFrEF

Other group

Description:

Selected prognostic factors will be analyzed in patients with LVEF ≤40%

Treatment:

Diagnostic Test: Diagostic tests

Identyfication of prognostic factors in HFmrEF

Other group

Description:

Selected prognostic factors will be analyzed in patients with LVEF 41-49%

Treatment:

Diagnostic Test: Diagostic tests

Identyfication of prognostic factors in HFpEF

Other group

Description:

Selected prognostic factors will be analyzed in patients with LVEF ≥50%

Treatment:

Diagnostic Test: Diagostic tests