Clinical trial NCT02963272: ST2 for the Management of Heart Failure - STADE-HF
Official title: Interest of ST2 to Diagnosis and Management of Patients With Heart Failure (HF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Diastolic Heart Failure
Systolic Heart Failure Stage C
Keywords: Heart failure
ST2
fibrosis
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2016-11-15
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

* Heart failure hospitalization

Exclusion Criteria:

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

Primary outcomes:
measure: Rehospitalization
timeFrame: 1 month
Secondary outcomes:
measure: Economic evaluation
timeFrame: 1 month and 1 year
measure: Mortality
timeFrame: 1 month and 1 year
measure: Biological markers of HF Assay
timeFrame: 1 month and 1 year
measure: Stay at hospital duration
timeFrame: 1 month and 1 year
measure: Markers of the renal function assay
timeFrame: 1 month and 1 year
measure: Rehospitalization for heart failure
timeFrame: 1 month and 1 year
measure: Rehospitalization for all causes
timeFrame: 1 month and 1 year
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University Regional Hospital Arnaud de Villeneuve
state: Languedoc-Roussillon
Study officials:
affiliation: University Hospital, Montpellier
name: François ROUBILLE, PU-PH
role: PRINCIPAL_INVESTIGATOR
References: