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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-A01433-54 | Registry Identifier | ID-RCB |
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| Name | Class |
|---|---|
| EURO BIO Scientific | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Usual management of heart failure. The sST-2 level will be blunted. | |
| Biomarker guided therapy | Experimental | Guided therapy using sST-2 monitoring at the discharge from initial hospitalisation, 6, 12, 18 and 24 months of following. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biomarker guided therapy | Biological | Guided therapy using sST-2 monitoring at the discharge from initial hospitalisation, 6, 12, 18 and 24 months of following. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cost-efficacy ratio | Cost to avoid an hospitalisation for heart failure | 2 years |
| Cost of initial hospitalisation and rehospitalisation | Including hospitalisation, imaging and biological analysis |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jean-Paul CRISTOL, MD, PhD | Contact | (0)4 67 33 83 14 | +33 | jp-cristol@chu-montpellier.fr |
| Anne-Marie GORCE DUPUY | Contact | (0)4 67 33 79 61 | am-dupuy@chu-montpellier.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lapeyronie Hospital | Active, not recruiting | Montpellier | Occitanie | 34295 | France | |
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).
24 months after randomisation
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Prospective
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| 2 years |
| Number of hospitalisation for heart failure | 30 days |
| Number of hospitalisation for heart failure | 2 years |
| CHU Angers |
| Recruiting |
| Angers |
| France |
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| CHU Besançon | Recruiting | Besançon | France |
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| CH Béziers | Recruiting | Béziers | France |
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| CHU Caen | Recruiting | Caen | France |
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| CHU Grenoble | Recruiting | Grenoble | France |
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| Arnaud de Villeneuve Hospital | Recruiting | Montpellier | France |
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| CHU Nimes | Recruiting | Nîmes | France |
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| APHP Pompidou | Not yet recruiting | Paris | France |
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| CHU Rennes | Not yet recruiting | Rennes | France |
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| CHU Toulouse | Recruiting | Toulouse | France |
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| CHU Vannes | Recruiting | Vannes | France |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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