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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03056651 |
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Date of registration:
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12/02/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Day-care Unit for Patients With Refractory Heart Failure
DayCare-HF |
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Scientific title:
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Day-care Unit for Patients With Refractory Heart Failure - a Single-centre Study |
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Date of first enrolment:
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April 2016 |
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Target sample size:
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200 |
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Recruitment status: |
Enrolling by invitation |
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URL:
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https://clinicaltrials.gov/show/NCT03056651 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Poland
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cardiovascular Diseases
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Heart Diseases
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Heart Failure
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Intervention(s)
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Other: treatment in day-care heart failure unit
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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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]
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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]
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Secondary ID(s)
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DCHFU
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DayCare-HF
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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