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)

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Biological: Biomarker guided therapy

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 Type: Interventional
• Enrollment (Estimated): 710
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jean-Paul CRISTOL, MD, PhD; Phone Number: +33 (0)4 67 33 83 14; Email: jp-cristol@chu-montpellier.fr
• Study Contact Backup: Name: Anne-Marie GORCE DUPUY; Phone Number: (0)4 67 33 79 61; Email: am-dupuy@chu-montpellier.fr

Study Locations

• France
  • Montpellier, France
    • Recruiting
    • Arnaud de villeneuve Hospital
    • Contact: Francois ROUBILLE, MD, phD; Phone Number: +33 04 67 33 61 82; Email: f-roubille@chu-montpellier.fr
  • Occitanie
    • Montpellier, Occitanie, France, 34295
      • Active, not recruiting
      • Lapeyronie Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Usual management of heart failure. The sST-2 level will be blunted.
Experimental: Biomarker guided therapy; Guided therapy using sST-2 monitoring at the discharge from initial hospitalisation, 6, 12, 18 and 24 months of following.	Biological: Biomarker guided therapy; Guided therapy using sST-2 monitoring at the discharge from initial hospitalisation, 6, 12, 18 and 24 months of following.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost-efficacy ratio	Cost to avoid an hospitalisation for heart failure	2 years
Cost of initial hospitalisation and rehospitalisation	Including hospitalisation, imaging and biological analysis	2 years
Number of hospitalisation for heart failure		30 days
Number of hospitalisation for heart failure		2 years

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: EURO BIO Scientific

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2021
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: September 14, 2020
• First Submitted That Met QC Criteria: September 14, 2020
• First Posted (Actual): September 18, 2020

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 6, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Biomarker; Heart failure; Guided therapy
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: RECHMPL19_0225 / UF 7799

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

The general goal is to make the study data available to interested researchers as well as to provide proof of transparency for the study. Data (and an accompanying data dictionary) will be de-identified and potentially further cleaned or aggregated as the investigators deem necessary to protect participant anonymity.

Data will be made available to persons who address a reasonable request to the study director and fulfil the requirements stipulated by the French CNIL (Commission National Informatic Liberty).

• IPD Sharing Time Frame: 24 months after randomisation
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No