Heart Failure, Diastolic Heart Failure, Systolic Heart Failure Stage C
Conditions
Keywords
Heart failure, ST2, fibrosis
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.
Interventions
Conventional strategy to manage the patients with HF, following the international guidelines.
OTHERST2-guided strategy
patients wit ST2 over the median are targeted with higher doses of drugs with putative effects on fibrosis and anti HF pathophysiology
Sponsors
University Hospital, Montpellier
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Heart failure hospitalization
Exclusion criteria
* Other study * Pregnancy, feeding * Refusal * Not possible to perform information
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rehospitalization | 1 month | The frequence of the rehospitalization of the patient according to the treatment received |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biological markers of HF Assay | 1 month and 1 year | Measure of biological marker ST2 |
| 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) |
| Stay at hospital duration | 1 month and 1 year | Evaluation of duration of hospitalisation |
| Mortality | 1 month and 1 year | measure of mortality |
| Rehospitalization for heart failure | 1 month and 1 year | Rehospitalization rate for heart failure |
| Rehospitalization for all causes | 1 month and 1 year | Rehospitalization rate for all causes |
| Markers of the renal function assay | 1 month and 1 year | Measure of biological marker of renal function |
Countries
France
Outcome results
None listed