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

February 14, 2023 updated by: French Cardiology Society
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Créteil, France, 94000
        • Hôpital Henri Mondor
      • Le Kremlin-Bicêtre, France, 94275
        • Hôpital Bicêtre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to rehospitalization
Time Frame: 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.
within the first 3 months after the randomization.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

French Cardiology Society

Collaborators

Agence Regionale de Sante d'Ile de France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2017

Primary Completion (Actual)

September 29, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

April 24, 2017

First Submitted That Met QC Criteria

May 16, 2017

First Posted (Actual)

May 17, 2017

Study Record Updates

Last Update Posted (Actual)

February 15, 2023

Last Update Submitted That Met QC Criteria

February 14, 2023

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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