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Day-care Unit for Patients With Refractory Heart Failure (DayCare-HF)

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ClinicalTrials.gov Identifier: NCT03056651
Recruitment Status : Enrolling by invitation
First Posted : February 17, 2017
Last Update Posted : May 27, 2020
Sponsor:
Information provided by (Responsible Party):
Mariusz Gasior, Silesian Centre for Heart Diseases

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.

Condition or disease Intervention/treatment Phase
Heart Failure Heart Diseases Cardiovascular Diseases Other: treatment in day-care heart failure unit Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Day-care Unit for Patients With Refractory Heart Failure - a Single-centre Study
Study Start Date : April 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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).
Other: treatment in day-care heart failure unit



Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03056651


Locations
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Poland
Silesian Centre for Heart Disease
Zabrze, Silesia, Poland, 41-800
Sponsors and Collaborators
Silesian Centre for Heart Diseases
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Responsible Party: Mariusz Gasior, MD, PhD, Professor, Silesian Centre for Heart Diseases
ClinicalTrials.gov Identifier: NCT03056651    
Other Study ID Numbers: DayCare-HF
DCHFU ( Other Identifier: Silesian Centre for Heart Disease )
First Posted: February 17, 2017    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020
Keywords provided by Mariusz Gasior, Silesian Centre for Heart Diseases:
heart failure
day care
prognosis
Additional relevant MeSH terms:
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Heart Failure
Cardiovascular Diseases
Heart Diseases