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

French Cardiology Society

Status: Terminated

Conditions: Heart Failure

Treatments: Procedure: HOME-based hospitalization

Study type: Interventional

Funder types: Other

Identifiers

NCT03156686

2016-07

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Control

No Intervention group

Description:

Patients will be randomly assigned to conventional hospital care

Home care treatment

Experimental group

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.

Treatment:

Procedure: HOME-based hospitalization