Day-care Unit for Patients With Refractory Heart Failure
DayCare-HF
2 other identifiers
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable heart-failure
Started Apr 2016
Longer than P75 for not_applicable heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 12, 2017
CompletedFirst Posted
Study publicly available on registry
February 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedMay 27, 2020
May 1, 2020
4.7 years
February 12, 2017
May 25, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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
Study Arms (1)
DayCare-HF
OTHERComprehensive 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).
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Inability to travel to the unit
- Non-compliance with the medical recommendations
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Silesian Centre for Heart Disease
Zabrze, Silesian Voivodeship, 41-800, Poland
MeSH Terms
Conditions
Interventions
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD, Professor
Study Record Dates
First Submitted
February 12, 2017
First Posted
February 17, 2017
Study Start
April 1, 2016
Primary Completion
December 1, 2020
Study Completion
December 1, 2022
Last Updated
May 27, 2020
Record last verified: 2020-05