ST2 for the Management of Heart Failure - STADE-HF

Heart Failure Clinical Trial

— STADE-HF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02963272
• Other study ID #: 9734
• Status: Completed
• Phase: N/A
• Start date: January 19, 2017
• Est. completion date: April 26, 2019

Study information

• Verified date: October 2021
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: April 26, 2019
• Est. primary completion date: April 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Heart failure hospitalization

Exclusion Criteria:

• Other study

• Pregnancy, feeding

• Refusal

• Not possible to perform information

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
France	University Regional Hospital Arnaud de Villeneuve	Montpellier	Languedoc-Roussillon

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rehospitalization	The frequence of the rehospitalization of the patient according to the treatment received	1 month
Secondary	Economic evaluation	Compare the hospitalization cost at 1 month and the cost of biological diagnostic strategies (NT-proBNP with or without ST2)	1 month and 1 year
Secondary	Mortality	measure of mortality	1 month and 1 year
Secondary	Biological markers of HF Assay	Measure of biological marker ST2	1 month and 1 year
Secondary	Stay at hospital duration	Evaluation of duration of hospitalisation	1 month and 1 year
Secondary	Markers of the renal function assay	Measure of biological marker of renal function	1 month and 1 year
Secondary	Rehospitalization for heart failure	Rehospitalization rate for heart failure	1 month and 1 year
Secondary	Rehospitalization for all causes	Rehospitalization rate for all causes	1 month and 1 year