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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
Silesian Centre for Heart Diseases
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring heart failure, day care, prognosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Optimally decongested heart failure in New York Heart Association (NYHA) class II-IV, treated for at least 6 months
  2. Performance of all possible reparative procedures if indications were present (cardiac revascularization, correction of valvular heart disease, cardiac ablation, cardiac resynchronization therapy)
  3. Implantation of cardioverter-defibrillator (ICD) if applicable
  4. At least two unplanned hospitalizations for heart failure during preceding 6 months

Exclusion Criteria:

  1. Inability to travel to the unit
  2. 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

First Posted
February 12, 2017
Last Updated
May 25, 2020
Sponsor
Silesian Centre for Heart Diseases
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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

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Day-care Unit for Patients With Refractory Heart Failure

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