Study Results
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Basic Information
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COMPLETED
NA
123 participants
INTERVENTIONAL
2017-01-19
2019-04-26
Brief Summary
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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.
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Detailed Description
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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. 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Conventional strategy
Conventional strategy to manage the patients with HF, following the international guidelines
Conventional strategy
Conventional strategy to manage the patients with HF, following the international guidelines.
ST2-guided strategy
Management of patients follow the international guidelines but are also guided by the ST2, to adapt the drugs indicated in patients with HF.
ST2-guided strategy
patients wit ST2 over the median are targeted with higher doses of drugs with putative effects on fibrosis and anti HF pathophysiology
Interventions
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Conventional strategy
Conventional strategy to manage the patients with HF, following the international guidelines.
ST2-guided strategy
patients wit ST2 over the median are targeted with higher doses of drugs with putative effects on fibrosis and anti HF pathophysiology
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Pregnancy, feeding
* Refusal
* Not possible to perform information
18 Years
ALL
No
Sponsors
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University Hospital, Montpellier
OTHER
Responsible Party
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Principal Investigators
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François ROUBILLE, PU-PH
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Montpellier
Locations
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University Regional Hospital Arnaud de Villeneuve
Montpellier, Languedoc-Roussillon, France
Countries
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Other Identifiers
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2016-A01148-43
Identifier Type: REGISTRY
Identifier Source: secondary_id
RECHMPL16_0194
Identifier Type: -
Identifier Source: org_study_id
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