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)

University Hospital Center (CHU)

Status: Enrolling

Conditions: Heart Failure

Treatments: Biological: Biomarker guided therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04554277

RECHMPL19_0225

2019-A01433-54 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 710 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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710 participants in 2 patient groups

Control

No Intervention group

Description:

Usual management of heart failure. The sST-2 level will be blunted.

Biomarker guided therapy

Experimental group

Description:

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

Treatment:

Biological: Biomarker guided therapy