Day-care Unit for Patients With Refractory Heart Failure (DayCare-HF)
Day-care Unit for Patients With Refractory Heart Failure - a Single-centre Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Silesia
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Zabrze, Silesia, Poland, 41-800
- Silesian Centre for Heart Disease
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
OTHER: DayCare-HF
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of participants with rehospitalization due to heart failure decompensation
Time Frame: From date of inclusion until the date of death from any cause, assessed up to 1 year
|
From date of inclusion until the date of death from any cause, assessed up to 1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of participants with major adverse cardiovascular event
Time Frame: From date of inclusion until the date of death from any cause, assessed up to 1 year
|
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
Time Frame: From date of inclusion until the date of death from any cause, assessed up to 1 year
|
From date of inclusion until the date of death from any cause, assessed up to 1 year
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DayCare-HF
- DCHFU (OTHER: Silesian Centre for Heart Disease)
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