ST2 for the Management of Heart Failure - STADE-HF

University Hospital Center (CHU)

Status: Completed

Conditions: Systolic Heart Failure Stage C; Diastolic Heart Failure; Heart Failure

Treatments: Other: ST2-guided strategy; Other: Conventional strategy

Study type: Interventional

Funder types: Other

Identifiers

NCT02963272

9734

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 123 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Heart failure hospitalization

Exclusion criteria

• Other study
• Pregnancy, feeding
• Refusal
• Not possible to perform information

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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123 participants in 2 patient groups

Conventional strategy

Other group

Description:

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

Treatment:

Other: Conventional strategy

ST2-guided strategy

Other group

Description:

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

Treatment:

Other: ST2-guided strategy