University Regional Hospital Arnaud de Villeneuve
Montpellier, Languedoc-Roussillon, 34295, France
NCT Number: NCT02963272
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Montpellier, Languedoc-Roussillon, 34295, France
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Conventional strategy to manage the patients with HF, following the international guidelines.
patients wit ST2 over the median are targeted with higher doses of drugs with putative effects on fibrosis and anti HF pathophysiology
Time frame: 1 month
The frequence of the rehospitalization of the patient according to the treatment received
Time frame: 1 month and 1 year
Compare the hospitalization cost at 1 month and the cost of biological diagnostic strategies (NT-proBNP with or without ST2)
Time frame: 1 month and 1 year
measure of mortality
Time frame: 1 month and 1 year
Measure of biological marker ST2
Time frame: 1 month and 1 year
Evaluation of duration of hospitalisation
Time frame: 1 month and 1 year
Measure of biological marker of renal function
Time frame: 1 month and 1 year
Rehospitalization rate for heart failure
Time frame: 1 month and 1 year
Rehospitalization rate for all causes
University Hospital, Montpellier
Other
Interest of ST2 to Diagnosis and Management of Patients With Heart Failure (HF)
Acronym: STADE-HF
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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