ST2 for the Management of Heart Failure - STADE-HF

Study Overview
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Brief Summary
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Heart failure (HF) is a severe disease, burdened with a poor prognosis (30% mortality at 2 years, 30% of rehospitalization within 1 month). It is also a major cause of health burden representing between 1.5 and 2 billions euros per year in France. Approximately 75% of these costs are due to hospitalization. Besides physical examination and echocardiography, biology may help refine the diagnosis, but also could provide powerful prognostic parameters. This study aims to assess the value of ST2 in the management of patients admitted for HF to reduce readmission at one month.

Detailed Description
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Background and rationale: Heart failure (HF) is a severe disease, burdened with a poor prognosis (30% mortality at 2 years, 30% of rehospitalization within 1 month). It is also a major cause of health burden representing between 1.5 and 2 billions euros per year in France. Approximately 75% of these costs are due to hospitalization. Besides physical examination and echocardiography, biology may help refine the diagnosis, but also could provide powerful prognostic parameters. The natriuretic peptides are already available and widely used to this purpose. Other biomarkers such as fibrosis markers are promising. In a recently published preliminary work of a cohort of 180 cardiac patients, ST2 is proving to be a powerful prognostic biomarker. This study aims to assess the value of ST2 in the management of patients admitted for HF to reduce readmission at one month. Primary and secondary endpoints: Primary endpoint: - Interest of ST2 to decrease rehospitalization at one month in patients admitted for HF in the cardiology department and / or Internal Medicine. Secondary objective: economic evaluation Clinical Target: mortality, stay at hospital duration Impact on biological markers of HF, renal function Population: Any adult being hospitalized for any type of HF. A total of 300 patients will be over a period of 36 months, divided into 2 arms. Methods: interventional, randomized, opened: the two strategies ST2 available versus ST2 not available will be compared The duration of patient participation is 12 months.

Official Title
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Interest of ST2 to Diagnosis and Management of Patients With Heart Failure (HF)

Conditions
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Heart Failure, Diastolic Heart Failure, Systolic Heart Failure Stage C

Intervention / Treatment
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* Other: Conventional strategy
* Other: ST2-guided strategy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Heart failure hospitalization Exclusion Criteria: Other study Pregnancy, feeding Refusal Not possible to perform information

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Conventional strategy<br>Conventional strategy to manage the patients with HF, following the international guidelines | Other: Conventional strategy<br>* Conventional strategy to manage the patients with HF, following the international guidelines.<br>|
| Other: ST2-guided strategy<br>Management of patients follow the international guidelines but are also guided by the ST2, to adapt the drugs indicated in patients with HF. | Other: ST2-guided strategy<br>* patients wit ST2 over the median are targeted with higher doses of drugs with putative effects on fibrosis and anti HF pathophysiology<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rehospitalization | The frequence of the rehospitalization of the patient according to the treatment received | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Economic evaluation | Compare the hospitalization cost at 1 month and the cost of biological diagnostic strategies (NT-proBNP with or without ST2) | 1 month and 1 year | 
| Mortality | measure of mortality | 1 month and 1 year | 
| Biological markers of HF Assay | Measure of biological marker ST2 | 1 month and 1 year | 
| Stay at hospital duration | Evaluation of duration of hospitalisation | 1 month and 1 year | 
| Markers of the renal function assay | Measure of biological marker of renal function | 1 month and 1 year | 
| Rehospitalization for heart failure | Rehospitalization rate for heart failure | 1 month and 1 year | 
| Rehospitalization for all causes | Rehospitalization rate for all causes | 1 month and 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart failure, ST2, fibrosis