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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 acronym: ICAME
StatusTerminated
PhaseNot applicable
Started2021-04-27
View on ClinicalTrials.gov ↗

Amendment history

2026-09-25
Trial terminated: The inclusions were halted due to problems with the supply of the kits required for sST2 assays
Final enrollment: 154 participants (planned 710)
Study completion confirmed: April 2026 (last estimated January 2027)
2025-09-24
Study Identification, Study Status, Oversight v8
Re-verified, no change to tracked fields
2025-05-13
Study Status v7
Primary completion date2026-04→2026-04-27
2024-07-15
Study Status, Contacts/Locations v6
Study sites2→12
2023-11-06
Study Status v5
Primary completion date2025-04→2026-04
Completion date2025-04→2027-01
Show 4 earlier versions
2021-12-31
Study Status v4
Primary completion date2023-11-15→2025-04
Completion date2024-04-15→2025-04
2021-05-05
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2020-11-15→confirmed 2021-04-27
Study sites1→2
2020-10-13
Study Status v2
Primary completion date2023-10-15→2023-11-15
Completion date2024-03-15→2024-04-15
Start date2020-10-15→2020-11-15
2020-09-18
Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility, IPDSharing v1
Eligibility criteria+40 characters
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 SchedulledScheduled valve surgery No fluent french Not able to provide informed [...]
Study description-3 characters
[...] inated from 10 centers will be included over a period of 12 monthesmonths and follow-up for 24 monthesmonths. All patients have an external evaluation at 6, 12, 18 and 24 monthesmonths. They were randomized into the usual treatment group (unkno [...]
2020-09-14
Original filing
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.
Trial Details
NCT Number NCT04554277
Lead Sponsor University Hospital, Montpellier
Collaborators: EURO BIO Scientific
Conditions Heart Failure
Enrollment 154 participants
Start Date 2021-04-27
Primary Completion 2026-04-14 (estimated)
Study Completion 2026-04-14 (estimated)
Updated on ClinicalTrials.gov 2026-09-24