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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-A01148-43 | Registry Identifier | ID-RCB |
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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.
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:
Methods: interventional, randomized, opened: the two strategies "ST2 available" versus "ST2 not available" will be compared The duration of patient participation is 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional strategy | Other | Conventional strategy to manage the patients with HF, following the international guidelines |
|
| ST2-guided strategy | Other | Management of patients follow the international guidelines but are also guided by the ST2, to adapt the drugs indicated in patients with HF. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional strategy | Other | Conventional strategy to manage the patients with HF, following the international guidelines. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rehospitalization | The frequence of the rehospitalization of the patient according to the treatment received | 1 month |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| François ROUBILLE, PU-PH | University Hospital, Montpellier | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Regional Hospital Arnaud de Villeneuve | Montpellier | Languedoc-Roussillon | 34295 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34046195 | Result | Huet F, Dupuy AM, Duflos C, Reis CA, Kuster N, Aguilhon S, Cristol JP, Roubille F. Soluble urokinase-type plasminogen activator receptor strongly predicts global mortality in acute heart failure patients: insight from the STADE-HF registry. Future Sci OA. 2021 Mar 29;7(5):FSO697. doi: 10.2144/fsoa-2020-0197. | |
| 32168423 | Result |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D054144 | Heart Failure, Diastolic |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ST2-guided strategy | Other | patients wit ST2 over the median are targeted with higher doses of drugs with putative effects on fibrosis and anti HF pathophysiology |
|
| 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 |
| Huet F, Nicoleau J, Dupuy AM, Curinier C, Breuker C, Castet-Nicolas A, Lotierzo M, Kalmanovich E, Zerkowski L, Akodad M, Adda J, Agullo A, Leclercq F, Pasquie JL, Battistella P, Roubille C, Fesler P, Mercier G, Bourel G, Cristol JP, Roubille F. STADE-HF (sST2 As a help for management of HF): a pilot study. ESC Heart Fail. 2020 Apr;7(2):774-778. doi: 10.1002/ehf2.12663. Epub 2020 Mar 13. |