Consultation at 8 Days to Reduce Hospitalisations in Heart Failure Patient

Study Overview
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Brief Summary
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Evaluate the benefit of systematic appointment with a cardiologist a week after hospitalisation for acute heart failure. Randomised, endpoint: number of day alive out of hospital during 6 months

Detailed Description
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Background: the risk for rehospitalisation is very high after hospitalisation for acute heart failure. Aim: evaluate the benefit of a consultation with a cardiologist, including echocardiography and education of the patient, between 7 and 15 days after discharge, in high risk patients, identified with BNP or incomplete therapy. Parallel randomised study. The main endpoint is the number of day alive out of hospital during the 6 months post discharge; statistics intention to treat comparison of the number of days alive out of hospital in the group with consultation compared with the group without consultation. Recruitment 3 years and 4 months, follow-up 6 months. Patients included have been hospitalised in hospital BICHAT 75018 Paris, France. Financing is by the ministry of health (PHRQHOS)

Official Title
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Consultation at 8 Days to Reduce Hospitalisations in Heart Failure Patient.

Conditions
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Acute Heart Failure

Intervention / Treatment
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* Other: Follow-up


Participation Criteria
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Eligibility Criteria
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Criteria of inclusion : Patient with decompensated heart failure hospitalized in the hospital BICHAT, For whom is planned a return at home, Valid (being able to return for a consultation to the hospital) Having Nt-ProBNP of exit ≥ 3500 ng /l and/or a non optimized treatment of exit - according to the doctor who has it the responsibility, Having signed the consent form by participation in the study. Criteria of not inclusion : Age < 18 years, Not membership in a national insurance scheme or in the Universal Health Coverage (CMU)(FREE UNIVERSAL HEALTH CARE)(A patient benefiting from the Medical aid of the State (AME) cannot be included) Participation to another protocol of research, Not being reachable by telephone in 6 months.

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>usual care without systematic cardiology evaluation between 1 and 2 weeks | |
| Experimental: Follow-up<br>Evaluation by a cardiologist using echocardiography, completed by education of the patient if necessary | Other: Follow-up<br>* Evaluation by a cardiologist using echocardiography, completed by education of the patient if necessary<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| days alive out of hospital 6 months post discharge |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rehospitalisation rate at 6 months |  | 6 months | 
| mortality at 3 and 6 months |  | 3 and 6 months | 
| number of patients receiving beta-blocker at 6 months |  | 6 months | 
| number of patients receiving a ACEI at 6 months |  | 6 months | 
| QOL at 6 months |  | 6 months | 
| autoevaluation of improvement/alteration of the patient state at 6 months |  | 6 months | 
| number of patients receiving beta-blocker at 3 months |  | 3 months | 
| number of patients receiving a ACEI at 3 months |  | 3 months | 
| QOL at 3 months |  | 3 months | 
| autoevaluation of improvement/alteration of the patient state at 3 months |  | 3 months | 
| number of patients having an optimal treatment at 6 months |  | 6 months | 
| number of patients having an optimal treatment at 3 months |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute heart failure; rehospitalisation; education; follow-up