SAFEty and Efficacy of HOME-based Hospitalization Versus Inpatient Care for Patients With Acute Heart Failure in Chronic Heart Failure.
NCT ID: NCT03156686
Last Updated: 2023-02-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
10 participants
INTERVENTIONAL
2017-06-01
2022-12-31
Brief Summary
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Detailed Description
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Hypothesis: Home care treatment (HC) will improve quality of live and decrease cost.
Methodology: Pilot, prospective, open, randomized controlled trial with 1-year follow-up for CHF patients admitted to 10 French hospital from March 2017 through February 2018, for acute decompensation of CHF. Patients will be randomly assigned to conventional hospital care or to the HC and treated with intravenous diuretics. Following discharge within 48 hours from the hospital, patients in the HC group will be treated at home. Follow-up will be conducted for both groups at discharge, 3 and 12 months after inclusion in the study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control
Patients will be randomly assigned to conventional hospital care
No interventions assigned to this group
Home care treatment
Patients will be randomly assigned to the HOME-based hospitalization and treated with intravenous diuretics. Following discharge within 48 hours from the hospital, patients in the HC group will be treated at home.
HOME-based hospitalization
patients in Home care treatment (HC) group will be treated at home
Interventions
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HOME-based hospitalization
patients in Home care treatment (HC) group will be treated at home
Eligibility Criteria
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Inclusion Criteria
* Identified in the first 48 hours
* Eligible for home-care with "Hospitalisation à Domicile" within 4 days after hospitalization.
* Patient affiliated to social security and to complementary health insurance
Exclusion Criteria
* Predominantly left-sided heart failure, dependent on oxygen because of the congestion
* Unexplored heart failure, indication of specific techniques (angiography) of device implantations (ICD, CRT).
* Severe cognitive disorders. Behavior disorders.
* Severe renal dysfunction with eGFR (MDRD) \< 15 mL/min/1.73m2
* Patient leaving alone
18 Years
ALL
No
Sponsors
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Agence Regionale de Sante d'Ile de France
OTHER_GOV
French Cardiology Society
OTHER
Responsible Party
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Principal Investigators
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Thibaud DAMY, MD
Role: PRINCIPAL_INVESTIGATOR
CH HENRI MONDOR
Locations
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Hôpital Henri Mondor
Créteil, , France
Hôpital Bicêtre
Le Kremlin-Bicêtre, , France
Countries
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Other Identifiers
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2016-07
Identifier Type: -
Identifier Source: org_study_id
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