Day-care Unit for Patients With Refractory Heart Failure

Study Overview
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Brief Summary
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The Day-Care Unit for Patients With Refractory Heart Failure (DayCare-HF) is an observational study on selected patients with advanced refractory heart failure. The purpose of the study was to examine the comprehensive management of HF in the day-care unit in terms of the safety and its impact on the rehospitalization and mortality rates in patients with advanced refractory HF.

Detailed Description
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The Day-Care Unit for Patients With Refractory Heart Failure (DayCare-HF) is a single-center observational study conducted in the 3rd Department of Cardiology, School of Medicine with the Division of Dentistry in Zabrze, Medical University of Silesia in Katowice, Silesian Centre for Heart Disease in Zabrze, Poland. The main objective of the DayCare-HF is to verify the hypothesis that comprehensive and multidisciplinary day-care management of patients with refractory heart failure (HF) is safe and beneficial in terms of hospital readmission due to HF and al cause mortality. The study population is formed by selected patients with heart failure, hospitalized in cardiology wards and intensive cardiac care unit of Silesian Centre for Heart Disease, who fulfilled eligibility criteria. During the scheduled visits comprehensive medical service is provided, including education, diagnostic tools (electrocardiography, transthoracic echocardiography, implanted cardioverter defibrillator (ICD) / cardiac resynchronization therapy device (CRT) interrogation and additional treatment (intravenous loop diuretic, dobutamine, vasodilators administration). The patients are under constant follow-up for major adverse events, heart transplantation, hospital readmissions due to HF and all cause mortality.

Official Title
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Day-care Unit for Patients With Refractory Heart Failure - a Single-centre Study

Conditions
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Heart Failure, Heart Diseases, Cardiovascular Diseases

Intervention / Treatment
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* Other: treatment in day-care heart failure unit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Optimally decongested heart failure in New York Heart Association (NYHA) class II-IV, treated for at least 6 months Performance of all possible reparative procedures if indications were present (cardiac revascularization, correction of valvular heart disease, cardiac ablation, cardiac resynchronization therapy) Implantation of cardioverter-defibrillator (ICD) if applicable At least two unplanned hospitalizations for heart failure during preceding 6 months Exclusion Criteria: Inability to travel to the unit Non-compliance with the medical recommendations

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: DayCare-HF<br>Comprehensive service in day-care unit, including education, diagnostic tools (i.e. electrocardiography, transthoracic echocardiography, implanted cardioverter defibrillator (ICD) / cardiac resynchronization therapy device (CRT) interrogation and possibility of intravenous drug administration (i.e. loop diuretics, dobutamine). | Other: treatment in day-care heart failure unit<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with rehospitalization due to heart failure decompensation |  | From date of inclusion until the date of death from any cause, assessed up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with major adverse cardiovascular event |  | From date of inclusion until the date of death from any cause, assessed up to 1 year | 
| Number of participants with reported deaths from any cause |  | From date of inclusion until the date of death from any cause, assessed up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heart failure, day care, prognosis