Heart Failure Clinical Trial
— ICAMEOfficial title:
Medico-economic Evaluation of Therapeutic Adaptation Guided by the Soluble Suppression of Tumorigenicity 2 (sST-2) Biomarker in the Management of Patients With Acute Heart Failure
Management of patients with heart Failure remains a major health concern because of the high rate of rehospitalization, mortality and induced-cost. Biomarkers could help to guide the management of patients with heart failure (HF). Soluble suppression of tumorigenicity 2 (sST2) appears as a promising biomarker. As a working hypothesis, we postulate that sST2 values monitoring could be an helpful guide for medical management in an attempt to reduce hospital readmission.
Status | Recruiting |
Enrollment | 710 |
Est. completion date | January 2027 |
Est. primary completion date | April 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion criteria: - 18 years or older - Hospitalization for heart failure (NTproBNP(N-terminal pro-Brain Natriuretic Peptid) =450 pg/ml (ou BNP =400 pg/ml) Exclusion criteria: - Waiting for heart transplantation - Scheduled valve surgery - No fluent french - Not able to provide informed consent - Hemodynamic instability - Poor outcome during the first week. - Pregnancy - Participating to other study |
Country | Name | City | State |
---|---|---|---|
France | Arnaud de Villeneuve Hospital | Montpellier | |
France | Lapeyronie Hospital | Montpellier | Occitanie |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Montpellier | EURO BIO Scientific |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cost-utility ratio | Cost will be compared between guided therapy using sST-2 levels and usual group. Utility will be derived from the French EQ5D (EuroQol 5 Dimensions), measured at 24 months. QALY (Quality Adjusted Life Years). |
2 years | |
Secondary | Cost-efficacy ratio | Cost to avoid an hospitalisation for heart failure | 2 years | |
Secondary | Cost of initial hospitalisation and rehospitalisation | Including hospitalisation, imaging and biological analysis | 2 years | |
Secondary | Number of hospitalisation for heart failure | 30 days | ||
Secondary | Number of hospitalisation for heart failure | 2 years |
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