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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biomarker guided therapy.
- Who it may be relevant to
- Registry conditions: Heart Failure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Biological Biomarker guided therapy
Guided therapy using sST-2 monitoring at the discharge from initial hospitalisation, 6, 12, 18 and 24 months of following.
Primary outcome measures
- Cost-utility ratio [Time frame: 2 years]
Secondary outcome measures (4)
- Cost-efficacy ratio [Time frame: 2 years]
- Cost of initial hospitalisation and rehospitalisation [Time frame: 2 years]
- Number of hospitalisation for heart failure [Time frame: 30 days]
- Number of hospitalisation for heart failure [Time frame: 2 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
France · 12 centers
- Lapeyronie Hospital — Montpellier
- CHU Angers — Angers
- CHU Besançon — Besançon
- CH Béziers — Béziers
- CHU Caen — Caen
- CHU Grenoble — Grenoble
- Arnaud de Villeneuve Hospital — Montpellier
- CHU Nimes — Nîmes
- … and 4 more centers
Identifiers
NCT: NCT04554277 · RECHMPL19_0225 · 2019-A01433-54