Day-care Unit for Patients With Refractory Heart Failure (DayCare-HF)
Primary Purpose
Heart Failure, Heart Diseases, Cardiovascular Diseases
Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
treatment in day-care heart failure unit
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring heart failure, day care, prognosis
Eligibility Criteria
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
Sites / Locations
- Silesian Centre for Heart Disease
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
DayCare-HF
Arm Description
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).
Outcomes
Primary Outcome Measures
Number of participants with rehospitalization due to heart failure decompensation
Secondary Outcome Measures
Number of participants with major adverse cardiovascular event
Number of participants with reported deaths from any cause
Full Information
NCT ID
NCT03056651
First Posted
February 12, 2017
Last Updated
May 25, 2020
Sponsor
Silesian Centre for Heart Diseases
1. Study Identification
Unique Protocol Identification Number
NCT03056651
Brief Title
Day-care Unit for Patients With Refractory Heart Failure
Acronym
DayCare-HF
Official Title
Day-care Unit for Patients With Refractory Heart Failure - a Single-centre Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Silesian Centre for Heart Diseases
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Heart Diseases, Cardiovascular Diseases
Keywords
heart failure, day care, prognosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DayCare-HF
Arm Type
Other
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
treatment in day-care heart failure unit
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Silesian Centre for Heart Disease
City
Zabrze
State/Province
Silesia
ZIP/Postal Code
41-800
Country
Poland
12. IPD Sharing Statement
Learn more about this trial
Day-care Unit for Patients With Refractory Heart Failure
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