Heart FailureSAFE-HOMENCT03156686
SAFEty and Efficacy of HOME-based Hospitalization Versus Inpatient Care for Patients With Acute Heart Failure in Chronic Heart Failure.
A study testing HOME-based hospitalization in people with Heart Failure, run by French Cardiology Society at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- HOME-based hospitalization
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Jun 2017to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
France2 sites
Hôpital Henri Mondor
Créteil, 94000
Hôpital Bicêtre
Le Kremlin-Bicêtre, 94275
About this study
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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- HOME-based hospitalization
- Keywords
- Acute Heart Failure, Chronic Heart Failure, Home care services, Cost-Benefit Analysis, Quality of life
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HOME-based hospitalizationProcedure or surgery
patients in Home care treatment (HC) group will be treated at home
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Patients will be randomly assigned to conventional hospital care |
| Home care treatment | Experimental | 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. Receives: Procedure: HOME-based hospitalization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to rehospitalization
Time to rehospitalization for a new episode of acute heart failure within the first 3 months after the randomization.
Measured: within the first 3 months after the randomization.
Secondary outcomes (6)
Occurrence of adverse events
Occurrence of adverse events evaluated at the end of the IV treatment which will be different for each patient.
Measured: during hospitalization at the end of the IV treatment which will be different for each patient, average of 15 days
Quality of life (scales)
Quality of life (scales) at the end of the treatment and 3 months
Measured: at the end of the treatment and 3 months
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.
Measured: at the end of the treatment and 3 months
Mortality at the end of the treatment, 3 months and 1 year
Mortality at the end of the treatment, 3 months and 1 year
Measured: at the end of the treatment, 3 months and 1 year
Cost-effectiveness
Cost-effectiveness at the end of the treatment, 3 months and 1 year
Measured: at the end of the treatment, 3 months and 1 year
Time to first rehospitalization
Time to first rehospitalization for a new episode of acute heart failure within the first year after the randomization.
Measured: within the first year after the randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start1 Jun 2017
- Primary completion29 Sep 2022
- Study completion31 Dec 2022
Why it stopped: Investigator couldn't include enough patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- French Cardiology Society
- Sponsor type
- University, hospital or other
- Collaborators
- Agence Regionale de Sante d'Ile de France
- Responsible party
- Sponsor
- Investigators
- Thibaud DAMY, MD, Principal investigator, CH HENRI MONDOR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03156686
- Sponsor's protocol ID
- 2016-07
- Acronym
- SAFE-HOME
- Status last verified
- Sep 2022
- First submitted
- 24 Apr 2017
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SAFEty and Efficacy of HOME-based Hospitalization Versus Inpatient Care for Patients With Acute Heart Failure in Chronic Heart Failure.
- ClinicalTrials.gov ID
- NCT03156686
- Acronym / sponsor ID
- SAFE-HOME / 2016-07
- Conditions
- Heart Failure
- Keywords
- Acute Heart Failure, Chronic Heart Failure, Home care services, Cost-Benefit Analysis, Quality of life
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigator couldn't include enough patients
- Enrolment
- 10 participants (actual)
- Lead sponsor
- French Cardiology SocietyUniversity, hospital or other
- Collaborators
- Agence Regionale de Sante d'Ile de France
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 29 Sep 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 17 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patients will be randomly assigned to conventional hospital care |
| Home care treatment | Experimental | Procedure: HOME-based hospitalizationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HOME-based hospitalizationpatients in Home care treatment (HC) group will be treated at home | Procedure or surgery | Home care treatment |
Primary outcome
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.
6 secondary outcomes
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
Quality of life (scales)
Time frame: at the end of the treatment and 3 months
Nutritional status
Time frame: 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
Cost-effectiveness
Time frame: at the end of the treatment, 3 months and 1 year
Time to first rehospitalization
Time frame: within the first year after the randomization.
Results and safety
The study was stopped early (reason given: Investigator couldn't include enough patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thibaud DAMY, MD principal investigator
CH HENRI MONDOR
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HOME-based hospitalization in people with Heart Failure, run by French Cardiology Society at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Investigator couldn't include enough patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to rehospitalization (time frame: within the first 3 months after the randomization.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2023.