Heart Failure
Conditions
Keywords
Heart failure, Biomarker, Guided therapy
Brief summary
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.
Detailed description
Methods : ICAME is a multicentric, blinded prospective randomized controlled trial. 710 patients originated from 10 centers will be included over a period of 12 months and follow-up for 24 months. All patients have an external evaluation at 6, 12, 18 and 24 months. They were randomized into the usual treatment group (unknown sST2 level) or the interventional treatment group, for whom sST2 level was known at all external consultation and used to guide the treatment. The primary endpoint was the QALY (Quality Adjusted Life Years). The secondary endpoints were the Cost-efficacy ratio, Cost to avoid an hospitalization for heart failure, the readmission rate for any cause at 1 month and at two years, and the evolution of cardiac remodelling determined by the collagene biomarkers.
Interventions
BIOLOGICALBiomarker guided therapy
Guided therapy using sST-2 monitoring at the discharge from initial hospitalisation, 6, 12, 18 and 24 months of following.
Sponsors
EURO BIO Scientific
University Hospital, Montpellier
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Intervention model description
Prospective
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cost-utility ratio | 2 years | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cost-efficacy ratio | 2 years | Cost to avoid an hospitalisation for heart failure |
| Cost of initial hospitalisation and rehospitalisation | 2 years | Including hospitalisation, imaging and biological analysis |
| Number of hospitalisation for heart failure | 30 days | — |
Countries
France
Contacts
Primary ContactJean-Paul CRISTOL, MD, PhD
Backup ContactAnne-Marie GORCE DUPUY
Outcome results
None listed