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

Not Applicable

Recruiting

• Conditions: Heart Failure
• Interventions: Biological: Biomarker guided therapy

• Registration Number: NCT04554277
• Lead Sponsor: University Hospital, Montpellier

Brief 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.

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 Timeline

• Study First Submitted: 2020-09-14
• Study First Submitted QC: 2020-09-14
• Study First Posted: 2020-09-18
• Study Start: 2021-04-27
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-14
• Primary Completion: 2026-04-27
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 710

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biomarker guided therapy	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

Name	Time	Method
Cost-utility ratio	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 Outcome Measures

Name	Time	Method
Cost-efficacy ratio	2 years	Cost to avoid an hospitalisation for heart failure
Number of hospitalisation for heart failure	2 years
Cost of initial hospitalisation and rehospitalisation	2 years	Including hospitalisation, imaging and biological analysis

Trial Locations

Locations (12)

APHP Pompidou; 🇫🇷 Paris, France

CH Béziers; 🇫🇷 Béziers, France

Lapeyronie Hospital; 🇫🇷 Montpellier, Occitanie, France

CHU Rennes; 🇫🇷 Rennes, France

CHU Nimes; 🇫🇷 Nîmes, France

CHU Vannes; 🇫🇷 Vannes, France

CHU Grenoble; 🇫🇷 Grenoble, France

CHU Caen; 🇫🇷 Caen, France

CHU Toulouse; 🇫🇷 Toulouse, France

CHU Angers; 🇫🇷 Angers, France

CHU Besançon; 🇫🇷 Besançon, France

Arnaud de Villeneuve Hospital; 🇫🇷 Montpellier, France