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

Heart Failure Clinical Trial

— ICAME  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04554277
• Other study ID #: RECHMPL19_0225 / UF 7799
• Status: Recruiting
• Phase: N/A
• Start date: April 27, 2021
• Est. completion date: January 2027

Study information

• Verified date: November 2023
• Source: University Hospital, Montpellier
• Contact: Jean-Paul CRISTOL, MD, PhD
• Phone: (0)4 67 33 83 14
• Email: jp-cristol[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 710
• Est. completion date: January 2027
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

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

Locations

Country	Name	City	State
France	Arnaud de Villeneuve Hospital	Montpellier
France	Lapeyronie Hospital	Montpellier	Occitanie

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Montpellier	EURO BIO Scientific

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cost-utility ratio	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).	2 years
Secondary	Cost-efficacy ratio	Cost to avoid an hospitalisation for heart failure	2 years
Secondary	Cost of initial hospitalisation and rehospitalisation	Including hospitalisation, imaging and biological analysis	2 years
Secondary	Number of hospitalisation for heart failure		30 days
Secondary	Number of hospitalisation for heart failure		2 years