Mediko-økonomisk evaluering af terapeutisk tilpasning styret af opløselig undertrykkelse af tumorigenicitet 2 (sST-2) biomarkør i behandlingen af patienter med akut hjertesvigt (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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
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Angers, Frankrig
- CHU Angers
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Besançon, Frankrig
- CHU Besançon
-
Béziers, Frankrig
- CH Béziers
-
Caen, Frankrig
- CHU Caen
-
Grenoble, Frankrig
- CHU Grenoble
-
Montpellier, Frankrig
- Arnaud de Villeneuve Hospital
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Nîmes, Frankrig
- CHU Nimes
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Paris, Frankrig
- APHP Pompidou
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Rennes, Frankrig
- CHU Rennes
-
Toulouse, Frankrig
- CHU Toulouse
-
Vannes, Frankrig
- CHU Vannes
-
-
Occitanie
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Montpellier, Occitanie, Frankrig, 34295
- Lapeyronie Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: Control
Usual management of heart failure. The sST-2 level will be blunted. |
|
|
Eksperimentel: Biomarker guided therapy
Guided therapy using sST-2 monitoring at the discharge from initial hospitalisation, 6, 12, 18 and 24 months of following. |
Guided therapy using sST-2 monitoring at the discharge from initial hospitalisation, 6, 12, 18 and 24 months of following. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Cost-utility ratio
Tidsramme: 2 years
|
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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Antal indlæggelser for hjertesvigt
Tidsramme: 30 dage
|
30 dage
|
|
|
Antal indlæggelser for hjertesvigt
Tidsramme: 2 år
|
2 år
|
|
|
Cost-efficacy ratio
Tidsramme: 2 years
|
Cost to avoid an hospitalisation for heart failure |
2 years
|
|
Cost of initial hospitalisation and rehospitalisation
Tidsramme: 2 years
|
Including hospitalisation, imaging and biological analysis |
2 years
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- RECHMPL19_0225
- 2019-A01433-54 (Registry Identifier: ID-RCB)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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-delingstidsramme
24 months after randomisation
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
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