ST2 for the Management of Heart Failure - STADE-HF

Not Applicable

Completed

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

• Registration Number: NCT02963272
• Lead Sponsor: University Hospital, Montpellier

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.

Study Timeline

• Study First Submitted: 2016-10-31
• Study First Submitted QC: 2016-11-09
• Study First Posted: 2016-11-15
• Study Start: 2017-01-19
• Primary Completion: 2019-04-26
• Study Completion: 2019-04-26
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-20
• Last Update Posted: 2021-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

Inclusion Criteria

• Heart failure hospitalization

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rehospitalization	1 month	The frequence of the rehospitalization of the patient according to the treatment received

Secondary Outcome Measures

Name	Time	Method
Rehospitalization for heart failure	1 month and 1 year	Rehospitalization rate for heart failure
Biological markers of HF Assay	1 month and 1 year	Measure of biological marker ST2
Stay at hospital duration	1 month and 1 year	Evaluation of duration of hospitalisation
Markers of the renal function assay	1 month and 1 year	Measure of biological marker of renal function
Economic evaluation	1 month and 1 year	Compare the hospitalization cost at 1 month and the cost of biological diagnostic strategies (NT-proBNP with or without ST2)
Rehospitalization for all causes	1 month and 1 year	Rehospitalization rate for all causes
Mortality	1 month and 1 year	measure of mortality

Trial Locations

Locations (1)

University Regional Hospital Arnaud de Villeneuve; 🇫🇷 Montpellier, Languedoc-Roussillon, France