Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04554277

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lapeyronie Hospital, Montpellier, Occitanie, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biomarker guided therapy

Biological

Guided therapy using sST-2 monitoring at the discharge from initial hospitalisation, 6, 12, 18 and 24 months of following.

Primary outcomes

  1. 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).

Secondary outcomes

  1. Cost-efficacy ratio

    Time frame: 2 years

    Cost to avoid an hospitalisation for heart failure

  2. Cost of initial hospitalisation and rehospitalisation

    Time frame: 2 years

    Including hospitalisation, imaging and biological analysis

  3. Number of hospitalisation for heart failure

    Time frame: 30 days

  4. Number of hospitalisation for heart failure

    Time frame: 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

Anne-Marie GORCE DUPUY

CONTACT

[email protected]

(0)4 67 33 79 61

Jean-Paul CRISTOL, MD, PhD

CONTACT

[email protected]

(0)4 67 33 83 14 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • EURO BIO Scientific

Registry information

Acronym: ICAME

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Sep 18, 2020
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.