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

Sponsor

French Cardiology Society (Other)

Overall Status

Recruiting

CT.gov ID

NCT03156686

Collaborator

Agence Regionale de Sante d'Ile de France (Other)

106

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Procedure: HOME-based hospitalization	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

106 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 1, 2017

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

No Intervention: Control

Patients will be randomly assigned to conventional hospital care

Experimental: 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.

Procedure: HOME-based hospitalization

patients in Home care treatment (HC) group will be treated at home

Outcome Measures

Primary Outcome Measures

Time to rehospitalization [within the first 3 months after the randomization.]
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 [during hospitalization at the end of the IV treatment which will be different for each patient, average of 15 days]
Occurrence of adverse events evaluated at the end of the IV treatment which will be different for each patient.
Quality of life (scales) [at the end of the treatment and 3 months]
Quality of life (scales) at the end of the treatment and 3 months
Nutritional status [at the end of the treatment and 3 months]
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 [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 [at the end of the treatment, 3 months and 1 year]
Cost-effectiveness at the end of the treatment, 3 months and 1 year
Time to first rehospitalization [within the first year after the randomization.]
Time to first rehospitalization for a new episode of acute heart failure within the first year after the randomization.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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