ST2 for the Management of Heart Failure - STADE-HF (STADE-HF)

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Diastolic Heart Failure; Systolic Heart Failure Stage C
• Intervention / Treatment: Other: Conventional strategy; Other: ST2-guided strategy

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 Type: Interventional
• Enrollment (Actual): 123
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Languedoc-Roussillon
    • Montpellier, Languedoc-Roussillon, France, 34295
      • University Regional Hospital Arnaud de Villeneuve

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Heart failure hospitalization

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Conventional strategy; Conventional strategy to manage the patients with HF, following the international guidelines	Other: Conventional strategy; Conventional strategy to manage the patients with HF, following the international guidelines.
Other: ST2-guided strategy; Management of patients follow the international guidelines but are also guided by the ST2, to adapt the drugs indicated in patients with HF.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rehospitalization	The frequence of the rehospitalization of the patient according to the treatment received	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Mortality	measure of mortality	1 month and 1 year
Biological markers of HF Assay	Measure of biological marker ST2	1 month and 1 year
Stay at hospital duration	Evaluation of duration of hospitalisation	1 month and 1 year
Markers of the renal function assay	Measure of biological marker of renal function	1 month and 1 year
Rehospitalization for heart failure	Rehospitalization rate for heart failure	1 month and 1 year
Rehospitalization for all causes	Rehospitalization rate for all causes	1 month and 1 year

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: François ROUBILLE, PU-PH, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2017
• Primary Completion (Actual): April 26, 2019
• Study Completion (Actual): April 26, 2019

Study Registration Dates

• First Submitted: October 31, 2016
• First Submitted That Met QC Criteria: November 9, 2016
• First Posted (Estimate): November 15, 2016

Study Record Updates

• Last Update Posted (Actual): October 21, 2021
• Last Update Submitted That Met QC Criteria: October 20, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Heart failure; ST2; fibrosis
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Heart Failure, Diastolic; Heart Failure, Systolic
• Other Study ID Numbers: 9734

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No