Heart Failure
Conditions
Keywords
Heart failure, Disease management program
Brief summary
After decompensated heart failure, a number of patients have high risk of early rehospitalization as well as death. Specialized medical management for a short period but very early after discharge could be critical for optimizing care and improving early outcome. This study aims to compare such early intensive medical management with usual care in high-risk patients after discharge.
Detailed description
At discharge, high-risk HF patients are selected and randomized in two groups: * Control group: usual disease management according to guidelines and including first medical consultation and biological test within the 4-week time following discharge. * Active group: consultations with HF specialist including biological test at weeks 1, 2 and 4 are planned in addition to usual management.
Interventions
OTHERConsultation with the general doctor or the cardiologist to J30 with blood results
OTHERNatriuretic peptides levels to J7 and J14
OTHERConsultations specialized to J7 and J14
Optimization of treatments Education on the signs of alert of the disease and on the medicines Reduction of the rate of BNP or NTproBNP = 30 % between the exit of the hospitalization and the second consultation Planning of an adapted coverage
OTHERPhone calls in 6 months and 12 months
OTHERNatriuretic peptides levels at 6 months
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years or more * consent signed * Acute or decompensated heart failure with one or more of following criteria:: * Discharge BNP \> 350 pg/ml or NTproBNP \> 2200 pg/ml * Discharge serum creatinine ≥ 180µM * Discharge systolic blood pressure ≤ 110mmHg * Previous hospitalisation for acute heart failure \< 6 months
Exclusion criteria
* acute coronary syndrome, * acute myocarditis, * isolated right HF, * transient HF, * planned cardiac surgery, * high risk of short-term non-cardiac death, * planned management within rehabilitation center/HF clinic at discharge
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with all cause death or unplanned hospitalization at 6 months | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Unplanned HF-related hospitalization at 6 and 12 months | 6 and 12 months |
| Number of alive and hospitalization-free days at 6 and 12 months | 6 and 12 months |
| Mean and distribution modified Goldman classe at 6 months | 6 months |
| Natriuretic peptides blood levels at 6 months. | 6 months. |
| All cause mortality at 12 months | one year |
| HF-treatment at 6 months | 6 months |
| Mean and distribution NYHA classe at 6 months | 6 months |
| Analysis of subgroups (LVEF altered or not, first HF episode or not, age> or ≤ 75, Changes in levels of BNP or NT-proBNP between day0 and the second consultation in the active group: ≥ 30% decrease, ≥ 30% increase, Intermediate variation). | 6 months |
| Biomarkers measured in plasma collected at day0: predictive value of the risk of death and hospitalization during the period of 6 months | 6 months |
| Global cost of patient management | from day0 to 12 months |
Countries
France
Outcome results
None listed