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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.
At discharge, high-risk HF patients are selected and randomized in two groups:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intensive disease management | Experimental | Planned consultations with HF specialist including biological test at weeks 1, 2 and 4; in addition to usual care. |
|
| usual disease management | Active Comparator | usual care according to guidelines; including first medical consultation and biological test within the 4-week time following discharge. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Natriuretic peptides levels to J7 and J14 | Other |
| ||
| Consultations specialized to J7 and J14 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with all cause death or unplanned hospitalization at 6 months | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| All cause mortality at 12 months | one year | |
| 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 |
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Inclusion Criteria:
18 years or more
consent signed
Acute or decompensated heart failure with one or more of following criteria::
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| LOGEART Damien, MD, PhD | Lariboisiere Hospital, APHP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Cardiologie - Hopital Lariboisière | Paris | 75010 | France |
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| Other |
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 |
|
| Phone calls in 6 months and 12 months | Other |
|
| Natriuretic peptides levels at 6 months | Other |
|
| Consultation with the general doctor or the cardiologist to J30 with blood results | Other |
|
| 6 and 12 months |
| Mean and distribution modified Goldman classe at 6 months | 6 months |
| Natriuretic peptides blood levels at 6 months. | 6 months. |
| Global cost of patient management | from day0 to 12 months |
| 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 |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D012017 | Referral and Consultation |
| ID | Term |
|---|---|
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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