Clinical trial NCT03156686: SAFEty and Efficacy of HOME-based Hospitalization Versus Inpatient Care for Patients With Acute Heart Failure in Chronic Heart Failure.
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
Overall status: TERMINATED
Phase: NA
Conditions: Heart Failure
Keywords: Acute Heart Failure
Chronic Heart Failure
Home care services
Cost-Benefit Analysis
Quality of life
Lead sponsor: French Cardiology Society
Sponsor class: OTHER
Collaborators: name: Agence Regionale de Sante d'Ile de France
First posted: 2017-05-17
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Time to rehospitalization
timeFrame: within the first 3 months after the randomization.
Secondary outcomes:
measure: Occurrence of adverse events
timeFrame: during hospitalization at the end of the IV treatment which will be different for each patient, average of 15 days
measure: Quality of life (scales)
timeFrame: at the end of the treatment and 3 months
measure: Nutritional status
timeFrame: at the end of the treatment and 3 months
measure: Mortality at the end of the treatment, 3 months and 1 year
timeFrame: at the end of the treatment, 3 months and 1 year
measure: Cost-effectiveness
timeFrame: at the end of the treatment, 3 months and 1 year
measure: Time to first rehospitalization
timeFrame: within the first year after the randomization.
Other outcomes:
Locations:
city: Créteil
country: France
facility: Hôpital Henri Mondor
city: Le Kremlin-Bicêtre
country: France
facility: Hôpital Bicêtre
Study officials:
affiliation: CH Henri Mondor
name: Thibaud DAMY, MD
role: PRINCIPAL_INVESTIGATOR
References: