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SAFEty and Efficacy of HOME-based Hospitalization Versus Inpatient Care for Patients With Acute Heart Failure in Chronic Heart Failure.
SAFE-HOME
1 other identifier
interventional
10
1 country
2
Brief Summary
Evaluation of the efficacy, safety and and cost of home care versus conventional hospitalization care at 3-months in patients with worsening chronic heart failure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable heart-failure
Started Jun 2017
Longer than P75 for not_applicable heart-failure
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 24, 2017
CompletedFirst Posted
Study publicly available on registry
May 17, 2017
CompletedStudy Start
First participant enrolled
June 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 29, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedFebruary 15, 2023
September 1, 2022
5.3 years
April 24, 2017
February 14, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to rehospitalization
Time to rehospitalization for a new episode of acute heart failure within the first 3 months after the randomization.
within the first 3 months after the randomization.
Secondary Outcomes (6)
Occurrence of adverse events
during hospitalization at the end of the IV treatment which will be different for each patient, average of 15 days
Quality of life (scales)
at the end of the treatment and 3 months
Nutritional status
at the end of the treatment and 3 months
Mortality at the end of the treatment, 3 months and 1 year
at the end of the treatment, 3 months and 1 year
Cost-effectiveness
at the end of the treatment, 3 months and 1 year
- +1 more secondary outcomes
Study Arms (2)
Control
NO INTERVENTIONPatients will be randomly assigned to conventional hospital care
Home care treatment
EXPERIMENTALPatients 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.
Interventions
patients in Home care treatment (HC) group will be treated at home
Eligibility Criteria
You may qualify if:
- Acute heart failure (with history of Chronic Heart Failure)
- 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
You may not qualify if:
- Under 18 years old
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Hôpital Henri Mondor
Créteil, 94000, France
Hôpital Bicêtre
Le Kremlin-Bicêtre, 94275, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thibaud DAMY, MD
CH HENRI MONDOR
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2017
First Posted
May 17, 2017
Study Start
June 1, 2017
Primary Completion
September 29, 2022
Study Completion
December 31, 2022
Last Updated
February 15, 2023
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share