Predictors of an Unfavorable Outcome in Patients With Heart Failure

NCT04753814 | Completed

• 1 other identifier: PMMHRI-BCO.39/2020
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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.

  One year after inclusion in the study

Study Arms (3)

Identyfication of prognostic factors in HFrEF

OTHER

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

Diagnostic Test: Diagostic tests

Identyfication of prognostic factors in HFmrEF

OTHER

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

Diagnostic Test: Diagostic tests

Identyfication of prognostic factors in HFpEF

OTHER

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

Diagnostic Test: Diagostic tests

Interventions

Diagostic tests DIAGNOSTIC_TEST

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.

Identyfication of prognostic factors in HFmrEF; Identyfication of prognostic factors in HFpEF; Identyfication of prognostic factors in HFrEF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Polish Mother Memorial Hospital Research Institute: lead

Study Sites (1)

Heart Failure Unit; Department of Cardiology and Congenital Diseases of Adults, Polish Mother's Memorial Hospital Research Institute

Lodz, 93-338, Poland

Location

Related Publications (1)

• 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.

  PMID: 27206819 RESULT

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Agata Bielecka-Dabrowa

  Heart Failure Unit; Department of Cardiology and Congenital Diseases of Adults, PMMHRI

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: February 15, 2021
• Study Start: February 1, 2019
• Primary Completion: February 28, 2020
• Study Completion: February 28, 2021
• Last Updated: December 20, 2021

Record last verified: 2021-01

Locations

PL (1)