ST2 for the Management of Heart Failure - STADE-HF (STADE-HF)
Primary Purpose
Heart Failure, Diastolic Heart Failure, Systolic Heart Failure Stage C
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Conventional strategy
ST2-guided strategy
Sponsored by
About this trial
This is an interventional diagnostic trial for Heart Failure focused on measuring Heart failure, ST2, fibrosis
Eligibility Criteria
Inclusion Criteria:
- Heart failure hospitalization
Exclusion Criteria:
- Other study
- Pregnancy, feeding
- Refusal
- Not possible to perform information
Sites / Locations
- University Regional Hospital Arnaud de Villeneuve
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Conventional strategy
ST2-guided strategy
Arm Description
Conventional strategy to manage the patients with HF, following the international guidelines
Management of patients follow the international guidelines but are also guided by the ST2, to adapt the drugs indicated in patients with HF.
Outcomes
Primary Outcome Measures
Rehospitalization
The frequence of the rehospitalization of the patient according to the treatment received
Secondary Outcome Measures
Economic evaluation
Compare the hospitalization cost at 1 month and the cost of biological diagnostic strategies (NT-proBNP with or without ST2)
Mortality
measure of mortality
Biological markers of HF Assay
Measure of biological marker ST2
Stay at hospital duration
Evaluation of duration of hospitalisation
Markers of the renal function assay
Measure of biological marker of renal function
Rehospitalization for heart failure
Rehospitalization rate for heart failure
Rehospitalization for all causes
Rehospitalization rate for all causes
Full Information
NCT ID
NCT02963272
First Posted
October 31, 2016
Last Updated
October 20, 2021
Sponsor
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT02963272
Brief Title
ST2 for the Management of Heart Failure - STADE-HF
Acronym
STADE-HF
Official Title
Interest of ST2 to Diagnosis and Management of Patients With Heart Failure (HF)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
January 19, 2017 (Actual)
Primary Completion Date
April 26, 2019 (Actual)
Study Completion Date
April 26, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Diastolic Heart Failure, Systolic Heart Failure Stage C
Keywords
Heart failure, ST2, fibrosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
123 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional strategy
Arm Type
Other
Arm Description
Conventional strategy to manage the patients with HF, following the international guidelines
Arm Title
ST2-guided strategy
Arm Type
Other
Arm Description
Management of patients follow the international guidelines but are also guided by the ST2, to adapt the drugs indicated in patients with HF.
Intervention Type
Other
Intervention Name(s)
Conventional strategy
Intervention Description
Conventional strategy to manage the patients with HF, following the international guidelines.
Intervention Type
Other
Intervention Name(s)
ST2-guided strategy
Intervention Description
patients wit ST2 over the median are targeted with higher doses of drugs with putative effects on fibrosis and anti HF pathophysiology
Primary Outcome Measure Information:
Title
Rehospitalization
Description
The frequence of the rehospitalization of the patient according to the treatment received
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Economic evaluation
Description
Compare the hospitalization cost at 1 month and the cost of biological diagnostic strategies (NT-proBNP with or without ST2)
Time Frame
1 month and 1 year
Title
Mortality
Description
measure of mortality
Time Frame
1 month and 1 year
Title
Biological markers of HF Assay
Description
Measure of biological marker ST2
Time Frame
1 month and 1 year
Title
Stay at hospital duration
Description
Evaluation of duration of hospitalisation
Time Frame
1 month and 1 year
Title
Markers of the renal function assay
Description
Measure of biological marker of renal function
Time Frame
1 month and 1 year
Title
Rehospitalization for heart failure
Description
Rehospitalization rate for heart failure
Time Frame
1 month and 1 year
Title
Rehospitalization for all causes
Description
Rehospitalization rate for all causes
Time Frame
1 month and 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Heart failure hospitalization
Exclusion Criteria:
Other study
Pregnancy, feeding
Refusal
Not possible to perform information
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François ROUBILLE, PU-PH
Organizational Affiliation
University Hospital, Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Regional Hospital Arnaud de Villeneuve
City
Montpellier
State/Province
Languedoc-Roussillon
ZIP/Postal Code
34295
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
ST2 for the Management of Heart Failure - STADE-HF
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