SAFEty and Efficacy of HOME-based Hospitalization Versus Inpatient Care for Patients With Acute Heart Failure in Chronic Heart Failure.

Study Overview
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Brief Summary
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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
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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.

Official Title
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SAFEty and Efficacy of HOME-based Hospitalization Versus Inpatient Care for Patients With Acute Heart Failure in Chronic Heart Failure.

Conditions
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Heart Failure

Intervention / Treatment
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* Procedure: HOME-based hospitalization


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Patients will be randomly assigned to conventional hospital care | |
| Experimental: Home care treatment<br>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. | Procedure: HOME-based hospitalization<br>* patients in Home care treatment (HC) group will be treated at home<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of adverse events | Occurrence of adverse events evaluated at the end of the IV treatment which will be different for each patient. | during hospitalization at the end of the IV treatment which will be different for each patient, average of 15 days | 
| Quality of life (scales) | Quality of life (scales) at the end of the treatment and 3 months | 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. | at the end of the treatment and 3 months | 
| Mortality at the end of the treatment, 3 months and 1 year | 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 | Cost-effectiveness at the end of the treatment, 3 months and 1 year | 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. | within the first year after the randomization. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quality of life, Acute Heart Failure, Chronic Heart Failure, Home care services, Cost-Benefit Analysis