NCT02963272

ST2 for the Management of Heart Failure - STADE-HF

Interest of ST2 to Diagnosis and Management of Patients With Heart Failure (HF)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure
• Diastolic Heart Failure
• Systolic Heart Failure Stage C

Interventions

Type	Name	Description
OTHER	Conventional strategy	Conventional strategy to manage the patients with HF, following the international guidelines.
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

Timeline

• Start date: 2017-01-19
• Primary completion: 2019-04-26
• Completion: 2019-04-26
• First posted: 2016-11-15
• Last updated: 2025-09-30

Locations

1 site across 1 country: France