An interventional study of Biomarker guided therapy in Heart Failure, sponsored by University Hospital, Montpellier. Terminated at 12 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Other
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.
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 154 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Usual management of heart failure. The sST-2 level will be blunted.
Guided therapy using sST-2 monitoring at the discharge from initial hospitalisation, 6, 12, 18 and 24 months of following.
Biological: Biomarker guided therapy
Guided therapy using sST-2 monitoring at the discharge from initial hospitalisation, 6, 12, 18 and 24 months of following.
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).
Time frame: 2 years
Cost-efficacy ratio
Cost to avoid an hospitalisation for heart failure
Time frame: 2 years
Cost of initial hospitalisation and rehospitalisation
Including hospitalisation, imaging and biological analysis
Time frame: 2 years
Number of hospitalisation for heart failure
Time frame: 30 days
Number of hospitalisation for heart failure
Time frame: 2 years
Plan to share: Yes — The general goal is to make the study data available to interested researchers as well as to provide proof of transparency for the study. Data (and an accompanying data dictionary) will be de-identified and potentially further cleaned or aggregated as the investigators deem necessary to protect participant anonymity. Data will be made available to persons who address a reasonable request to the study director and fulfil the requirements stipulated by the French CNIL (Commission National Informatic Liberty).
Supporting information: Study protocol
No publications or documents are linked to this record.
This study is terminated, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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University Hospital, Montpellier