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

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ClinicalTrials.gov Identifier: NCT03156686
Recruitment Status : Recruiting
First Posted : May 17, 2017
Last Update Posted : August 2, 2018
Sponsor:
Collaborator:
Agence Regionale de Sante d'Ile de France
Information provided by (Responsible Party):
French Cardiology Society

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 Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 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 : June 1, 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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.

  4. 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

  5. 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

  6. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03156686


Contacts
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Contact: Thibaud DAMY +33 149812253 thibaud.damy@aphp.fr
Contact: Justine POLLET 0143223333 justine.pollet@sfcardio.fr

Locations
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France
Hôpital Henri Mondor Recruiting
Créteil, France, 94000
Contact: Thibaud DAMY         
Principal Investigator: Thibaud DAMY         
Sponsors and Collaborators
French Cardiology Society
Agence Regionale de Sante d'Ile de France

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Responsible Party: French Cardiology Society
ClinicalTrials.gov Identifier: NCT03156686     History of Changes
Other Study ID Numbers: 2016-07
First Posted: May 17, 2017    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by French Cardiology Society:
Acute Heart Failure
Chronic Heart Failure
Home care services
Cost-Benefit Analysis
Quality of life
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases