Early Care After Discharge of HF Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Usefulness of a Short-time But Very Early Specialized Follow-up After Hospitalization for Acute Heart Failure: a Randomized Controlled Trial.

Conditions
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Heart Failure

Intervention / Treatment
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* Other: Natriuretic peptides levels to J7 and J14
* Other: Consultations specialized to J7 and J14
* Other: 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intensive disease management<br>Planned consultations with HF specialist including biological test at weeks 1, 2 and 4; in addition to usual care. | Other: Natriuretic peptides levels to J7 and J14<br> <br> Other: Consultations specialized to J7 and J14<br>* 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<br>Other: Phone calls in 6 months and 12 months<br> <br> Other: Natriuretic peptides levels at 6 months<br> <br> Other: Consultation with the general doctor or the cardiologist to J30 with blood results<br> <br> |
| Active Comparator: usual disease management<br>usual care according to guidelines; including first medical consultation and biological test within the 4-week time following discharge. | Other: Phone calls in 6 months and 12 months<br> <br> Other: Natriuretic peptides levels at 6 months<br> <br> Other: Consultation with the general doctor or the cardiologist to J30 with blood results<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with all cause death or unplanned hospitalization at 6 months |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart failure, Disease management program