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 (ICAME)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Angers, France
- CHU Angers
-
Besançon, France
- CHU Besançon
-
Béziers, France
- CH Béziers
-
Caen, France
- CHU Caen
-
Grenoble, France
- CHU Grenoble
-
Montpellier, France
- Arnaud de Villeneuve Hospital
-
Nîmes, France
- CHU Nimes
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Paris, France
- APHP Pompidou
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Rennes, France
- CHU Rennes
-
Toulouse, France
- CHU Toulouse
-
Vannes, France
- CHU Vannes
-
-
Occitanie
-
Montpellier, Occitanie, France, 34295
- Lapeyronie Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
Usual management of heart failure. The sST-2 level will be blunted. |
|
|
Experimental: Biomarker guided therapy
Guided therapy using sST-2 monitoring at the discharge from initial hospitalisation, 6, 12, 18 and 24 months of following. |
Guided therapy using sST-2 monitoring at the discharge from initial hospitalisation, 6, 12, 18 and 24 months of following. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cost-utility ratio
Time Frame: 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). |
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of hospitalisation for heart failure
Time Frame: 30 days
|
30 days
|
|
|
Number of hospitalisation for heart failure
Time Frame: 2 years
|
2 years
|
|
|
Cost-efficacy ratio
Time Frame: 2 years
|
Cost to avoid an hospitalisation for heart failure |
2 years
|
|
Cost of initial hospitalisation and rehospitalisation
Time Frame: 2 years
|
Including hospitalisation, imaging and biological analysis |
2 years
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RECHMPL19_0225
- 2019-A01433-54 (Registry Identifier: ID-RCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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).
IPD Sharing Time Frame
24 months after randomisation
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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