Clinical trial 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Keywords: Heart failure
Biomarker
Guided therapy
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: EURO BIO Scientific
First posted: 2020-09-18
Enrollment: 710
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cost-utility ratio
timeFrame: 2 years
Secondary outcomes:
measure: Cost-efficacy ratio
timeFrame: 2 years
measure: Cost of initial hospitalisation and rehospitalisation
timeFrame: 2 years
measure: Number of hospitalisation for heart failure
timeFrame: 30 days
measure: Number of hospitalisation for heart failure
timeFrame: 2 years
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Lapeyronie Hospital
state: Occitanie
city: Angers
country: France
facility: CHU Angers
city: Besançon
country: France
facility: CHU Besançon
city: Béziers
country: France
facility: CH Béziers
city: Caen
country: France
facility: CHU Caen
city: Grenoble
country: France
facility: CHU Grenoble
city: Montpellier
country: France
facility: Arnaud de Villeneuve Hospital
city: Nîmes
country: France
facility: CHU Nimes
city: Paris
country: France
facility: APHP Pompidou
city: Rennes
country: France
facility: CHU Rennes
city: Toulouse
country: France
facility: CHU Toulouse
city: Vannes
country: France
facility: CHU Vannes
Study officials:
References: