Back to resultsSAFEty and Efficacy of HOME-based Hospitalization Versus Inpatient Care for Patients With Acute Heart Failure in Chronic Heart Failure. (SAFE-HOME)
Primary Purpose
Heart Failure
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
HOME-based hospitalization
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Acute Heart Failure, Chronic Heart Failure, Home care services, Cost-Benefit Analysis, Quality of life
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Hôpital Henri Mondor
- Hôpital Bicêtre
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Home care treatment
Arm Description
Patients will be randomly assigned to conventional hospital care
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.
Outcomes
Primary Outcome Measures
Time to rehospitalization
Time to rehospitalization for a new episode of acute heart failure within the first 3 months after the randomization.
Secondary Outcome Measures
Occurrence of adverse events
Occurrence of adverse events evaluated at the end of the IV treatment which will be different for each patient.
Quality of life (scales)
Quality of life (scales) at the end of the treatment and 3 months
Nutritional status
Evaluation of the nutritional status based on MNA score at the beginning of the IV treatment and 3 months and dietary survey at the beginning and the end of the IV treatment.
Mortality at the end of the treatment, 3 months and 1 year
Mortality at the end of the treatment, 3 months and 1 year
Cost-effectiveness
Cost-effectiveness at the end of the treatment, 3 months and 1 year
Time to first rehospitalization
Time to first rehospitalization for a new episode of acute heart failure within the first year after the randomization.
Full Information
NCT ID
NCT03156686
First Posted
April 24, 2017
Last Updated
February 14, 2023
Sponsor
French Cardiology Society
Collaborators
Agence Regionale de Sante d'Ile de France
1. Study Identification
Unique Protocol Identification Number
NCT03156686
Brief Title
SAFEty and Efficacy of HOME-based Hospitalization Versus Inpatient Care for Patients With Acute Heart Failure in Chronic Heart Failure.
Acronym
SAFE-HOME
Official Title
SAFEty and Efficacy of HOME-based Hospitalization Versus Inpatient Care for Patients With Acute Heart Failure in Chronic Heart Failure.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Terminated
Why Stopped
Investigator couldn't include enough patients
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
September 29, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
French Cardiology Society
Collaborators
Agence Regionale de Sante d'Ile de France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Chronic heart failure (CHF) has an important socio-economic impact due to frequent hospital readmissions.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Acute Heart Failure, Chronic Heart Failure, Home care services, Cost-Benefit Analysis, Quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients will be randomly assigned to conventional hospital care
Arm Title
Home care treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
HOME-based hospitalization
Intervention Description
patients in Home care treatment (HC) group will be treated at home
Primary Outcome Measure Information:
Title
Time to rehospitalization
Description
Time to rehospitalization for a new episode of acute heart failure within the first 3 months after the randomization.
Time Frame
within the first 3 months after the randomization.
Secondary Outcome Measure Information:
Title
Occurrence of adverse events
Description
Occurrence of adverse events evaluated at the end of the IV treatment which will be different for each patient.
Time Frame
during hospitalization at the end of the IV treatment which will be different for each patient, average of 15 days
Title
Quality of life (scales)
Description
Quality of life (scales) at the end of the treatment and 3 months
Time Frame
at the end of the treatment and 3 months
Title
Nutritional status
Description
Evaluation of the nutritional status based on MNA score at the beginning of the IV treatment and 3 months and dietary survey at the beginning and the end of the IV treatment.
Time Frame
at the end of the treatment and 3 months
Title
Mortality at the end of the treatment, 3 months and 1 year
Description
Mortality at the end of the treatment, 3 months and 1 year
Time Frame
at the end of the treatment, 3 months and 1 year
Title
Cost-effectiveness
Description
Cost-effectiveness at the end of the treatment, 3 months and 1 year
Time Frame
at the end of the treatment, 3 months and 1 year
Title
Time to first rehospitalization
Description
Time to first rehospitalization for a new episode of acute heart failure within the first year after the randomization.
Time Frame
within the first year after the randomization.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thibaud DAMY, MD
Organizational Affiliation
CH Henri Mondor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Henri Mondor
City
Créteil
ZIP/Postal Code
94000
Country
France
Facility Name
Hôpital Bicêtre
City
Le Kremlin-Bicêtre
ZIP/Postal Code
94275
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
SAFEty and Efficacy of HOME-based Hospitalization Versus Inpatient Care for Patients With Acute Heart Failure in Chronic Heart Failure.
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