Skip to main content
OpenTrials
Completed

NCT Number: NCT02963272

ST2 for the Management of Heart Failure - STADE-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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Regional Hospital Arnaud de Villeneuve

Montpellier, Languedoc-Roussillon, 34295, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Heart failure hospitalization

Exclusion criteria

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

Treatment and study plan

Conventional strategy

Other

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

ST2-guided strategy

Other

patients wit ST2 over the median are targeted with higher doses of drugs with putative effects on fibrosis and anti HF pathophysiology

Primary outcomes

  1. Rehospitalization

    Time frame: 1 month

    The frequence of the rehospitalization of the patient according to the treatment received

Secondary outcomes

  1. Economic evaluation

    Time frame: 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)

  2. Mortality

    Time frame: 1 month and 1 year

    measure of mortality

  3. Biological markers of HF Assay

    Time frame: 1 month and 1 year

    Measure of biological marker ST2

  4. Stay at hospital duration

    Time frame: 1 month and 1 year

    Evaluation of duration of hospitalisation

  5. Markers of the renal function assay

    Time frame: 1 month and 1 year

    Measure of biological marker of renal function

  6. Rehospitalization for heart failure

    Time frame: 1 month and 1 year

    Rehospitalization rate for heart failure

  7. Rehospitalization for all causes

    Time frame: 1 month and 1 year

    Rehospitalization rate for all causes

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: STADE-HF

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 15, 2016
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.