ST2 for the Management of Heart Failure - STADE-HF

NCT ID: NCT02963272

Last Updated: 2025-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-19

Study Completion Date

2019-04-26

Brief Summary

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Heart failure (HF) is a severe disease, burdened with a poor prognosis (30% mortality at 2 years, 30% of rehospitalization within 1 month). It is also a major cause of health burden representing between 1.5 and 2 billions euros per year in France. Approximately 75% of these costs are due to hospitalization.

Besides physical examination and echocardiography, biology may help refine the diagnosis, but also could provide powerful prognostic parameters.

This study aims to assess the value of ST2 in the management of patients admitted for HF to reduce readmission at one month.

Detailed Description

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Background and rationale:

Heart failure (HF) is a severe disease, burdened with a poor prognosis (30% mortality at 2 years, 30% of rehospitalization within 1 month). It is also a major cause of health burden representing between 1.5 and 2 billions euros per year in France. Approximately 75% of these costs are due to hospitalization.

Besides physical examination and echocardiography, biology may help refine the diagnosis, but also could provide powerful prognostic parameters. The natriuretic peptides are already available and widely used to this purpose. Other biomarkers such as fibrosis markers are promising. In a recently published preliminary work of a cohort of 180 cardiac patients, ST2 is proving to be a powerful prognostic biomarker.

This study aims to assess the value of ST2 in the management of patients admitted for HF to reduce readmission at one month.

Primary and secondary endpoints:

Primary endpoint:

\- Interest of ST2 to decrease rehospitalization at one month in patients admitted for HF in the cardiology department and / or Internal Medicine.

Secondary objective:

* economic evaluation
* Clinical Target: mortality, stay at hospital duration
* Impact on biological markers of HF, renal function Population: Any adult being hospitalized for any type of HF. A total of 300 patients will be over a period of 36 months, divided into 2 arms.

Methods: interventional, randomized, opened: the two strategies "ST2 available" versus "ST2 not available" will be compared The duration of patient participation is 12 months.

Conditions

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Heart Failure Diastolic Heart Failure Systolic Heart Failure Stage C

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Conventional strategy

Conventional strategy to manage the patients with HF, following the international guidelines

Group Type OTHER

Conventional strategy

Intervention Type OTHER

Conventional strategy to manage the patients with HF, following the international guidelines.

ST2-guided strategy

Management of patients follow the international guidelines but are also guided by the ST2, to adapt the drugs indicated in patients with HF.

Group Type OTHER

ST2-guided strategy

Intervention Type OTHER

patients wit ST2 over the median are targeted with higher doses of drugs with putative effects on fibrosis and anti HF pathophysiology

Interventions

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Conventional strategy

Conventional strategy to manage the patients with HF, following the international guidelines.

Intervention Type OTHER

ST2-guided strategy

patients wit ST2 over the median are targeted with higher doses of drugs with putative effects on fibrosis and anti HF pathophysiology

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Heart failure hospitalization

Exclusion Criteria

* Other study
* Pregnancy, feeding
* Refusal
* Not possible to perform information
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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François ROUBILLE, PU-PH

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

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University Regional Hospital Arnaud de Villeneuve

Montpellier, Languedoc-Roussillon, France

Site Status

Countries

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France

Other Identifiers

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2016-A01148-43

Identifier Type: REGISTRY

Identifier Source: secondary_id

RECHMPL16_0194

Identifier Type: -

Identifier Source: org_study_id

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