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

Last updated: July 15, 2024
Sponsor: University Hospital, Montpellier
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Failure

Congestive Heart Failure

Chest Pain

Treatment

Biomarker guided therapy

Clinical Study ID

NCT04554277
RECHMPL19_0225 / UF 7799
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 Design

Total Participants: 710
Treatment Group(s): 1
Primary Treatment: Biomarker guided therapy
Phase:
Study Start date:
April 27, 2021
Estimated Completion Date:
January 31, 2027

Study 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.

Connect with a study center

  • Lapeyronie Hospital

    Montpellier, Occitanie 34295
    France

    Site Not Available

  • CHU Angers

    Angers,
    France

    Active - Recruiting

  • CHU Besançon

    Besançon,
    France

    Active - Recruiting

  • CH Béziers

    Béziers,
    France

    Active - Recruiting

  • CHU Caen

    Caen,
    France

    Active - Recruiting

  • CHU Grenoble

    Grenoble,
    France

    Active - Recruiting

  • Arnaud de Villeneuve Hospital

    Montpellier,
    France

    Active - Recruiting

  • CHU Nimes

    Nîmes,
    France

    Active - Recruiting

  • APHP Pompidou

    Paris,
    France

    Site Not Available

  • CHU Rennes

    Rennes,
    France

    Site Not Available

  • CHU Toulouse

    Toulouse,
    France

    Active - Recruiting

  • CHU Vannes

    Vannes,
    France

    Active - Recruiting

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