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)

  • STATUS
    Recruiting
  • End date
    Apr 22, 2025
  • participants needed
    710
  • sponsor
    University Hospital, Montpellier
Updated on 22 March 2022
heart failure
acute heart failure
n-terminal pro-bnp

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.

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.

Details
Condition Heart Failure
Treatment Biomarker guided therapy
Clinical Study IdentifierNCT04554277
SponsorUniversity Hospital, Montpellier
Last Modified on22 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
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