Heart FailureDayCare-HFNCT03056651
Day-care Unit for Patients With Refractory Heart Failure
A study testing treatment in day-care heart failure unit in people with Heart Failure and Heart Diseases, run by Silesian Centre for Heart Diseases at 1 site in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Heart Diseases, Cardiovascular Diseases
- What is being tested?
- treatment in day-care heart failure unit
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 sitePoland
- Study dates
- Apr 2016to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Inability to travel to the unit
- Non-compliance with the medical recommendations
Trial locations and contacts
1 site in 1 country.
Poland1 site
Silesian Centre for Heart Disease
Zabrze, Silesian Voivodeship, 41-800
About this study
Official title: Day-care Unit for Patients With Refractory Heart Failure - a Single-centre Study
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.
Read the 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.
- Conditions
- Heart Failure, Heart Diseases, Cardiovascular Diseases
- Being tested
- treatment in day-care heart failure unit
- Keywords
- heart failure, day care, prognosis
- Medical subject headings
- Heart Failure, Heart Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treatment in day-care heart failure unitOther
| Study group | Role | What they receive |
|---|---|---|
| DayCare-HF | Other | 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). Receives: Other: treatment in day-care heart failure unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with rehospitalization due to heart failure decompensation
Measured: 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
Measured: 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
Measured: From date of inclusion until the date of death from any cause, assessed up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2017
- Study startApr 2016
- Primary completionDec 2020 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Silesian Centre for Heart Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariusz Gasior, Silesian Centre for Heart Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03056651
- Sponsor's protocol ID
- DayCare-HF
- Other IDs
- DCHFU
- Acronym
- DayCare-HF
- Status last verified
- May 2020
- First submitted
- 12 Feb 2017
- Last updated
- 27 May 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Day-care Unit for Patients With Refractory Heart Failure - a Single-centre Study
- ClinicalTrials.gov ID
- NCT03056651
- Acronym / sponsor ID
- DayCare-HF / DayCare-HF
- Conditions
- Heart Failure, Heart Diseases, Cardiovascular Diseases
- Keywords
- heart failure, day care, prognosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Silesian Centre for Heart DiseasesUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 17 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DayCare-HF | Other | Other: treatment in day-care heart failure unitComprehensive 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Inability to travel to the unit
- Non-compliance with the medical recommendations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| treatment in day-care heart failure unit | Other | DayCare-HF |
Primary outcome
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
2 secondary outcomes
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing treatment in day-care heart failure unit in people with Heart Failure and Heart Diseases, run by Silesian Centre for Heart Diseases at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2020.