SAFEty and Efficacy of HOME-based Hospitalization Versus Inpatient Care for Patients With Acute Heart Failure in Chronic Heart Failure.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 10
- Locations
- 4
- Primary Endpoint
- Time to rehospitalization
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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 Outcomes
- Quality of life (scales)(at the end of the treatment and 3 months)
- Nutritional status(at the end of the treatment and 3 months)
- Cost-effectiveness(at the end of the treatment, 3 months and 1 year)
- Occurrence of adverse events(during hospitalization at the end of the IV treatment which will be different for each patient, average of 15 days)
- Mortality 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(within the first year after the randomization.)