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

Heart Failure Clinical Trial

— SAFE-HOME  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03156686
• Other study ID #: 2016-07
• Status: Terminated
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2022
• Source: French Cardiology Society
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: December 31, 2022
• Est. primary completion date: September 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Procedure:
• HOME-based hospitalization
patients in Home care treatment (HC) group will be treated at home

Locations

Country	Name	City	State
France	Hôpital Henri Mondor	Créteil
France	Hôpital Bicêtre	Le Kremlin-Bicêtre

Sponsors (2)

Lead Sponsor	Collaborator
French Cardiology Society	Agence Regionale de Sante d'Ile de France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.