Heart FailureSTADE-HFNCT02963272
ST2 for the Management of Heart Failure - STADE-HF
A study testing Conventional strategy and ST2-guided strategy in people with Heart Failure and Diastolic Heart Failure, run by University Hospital, Montpellier at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Diastolic Heart Failure, Systolic Heart Failure Stage C
- What is being tested?
- Conventional strategy and ST2-guided strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jan 2017to 26 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Heart failure hospitalization
Who cannot join
- Other study
- Pregnancy, feeding
- Refusal
- Not possible to perform information
Trial locations and contacts
1 site in 1 country.
France1 site
University Regional Hospital Arnaud de Villeneuve
Montpellier, Languedoc-Roussillon, 34295
About this study
Official title: 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.
Read the 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.
- Being tested
- Conventional strategy, ST2-guided strategy
- Keywords
- Heart failure, ST2, fibrosis
- Medical subject headings
- Heart Failure, Heart Failure, Diastolic, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional strategyOther
Conventional strategy to manage the patients with HF, following the international guidelines.
ST2-guided strategyOther
patients wit ST2 over the median are targeted with higher doses of drugs with putative effects on fibrosis and anti HF pathophysiology
| Study group | Role | What they receive |
|---|---|---|
| Conventional strategy | Other | Conventional strategy to manage the patients with HF, following the international guidelines Receives: Other: Conventional strategy |
| ST2-guided strategy | Other | Management of patients follow the international guidelines but are also guided by the ST2, to adapt the drugs indicated in patients with HF. Receives: Other: ST2-guided strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rehospitalization
The frequence of the rehospitalization of the patient according to the treatment received
Measured: 1 month
Secondary outcomes (7)
Economic evaluation
Compare the hospitalization cost at 1 month and the cost of biological diagnostic strategies (NT-proBNP with or without ST2)
Measured: 1 month and 1 year
Mortality
measure of mortality
Measured: 1 month and 1 year
Biological markers of HF Assay
Measure of biological marker ST2
Measured: 1 month and 1 year
Stay at hospital duration
Evaluation of duration of hospitalisation
Measured: 1 month and 1 year
Markers of the renal function assay
Measure of biological marker of renal function
Measured: 1 month and 1 year
Rehospitalization for heart failure
Rehospitalization rate for heart failure
Measured: 1 month and 1 year
Rehospitalization for all causes
Rehospitalization rate for all causes
Measured: 1 month and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2016 (estimated)
- Study start19 Jan 2017
- Primary completion26 Apr 2019
- Study completion26 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François ROUBILLE, PU-PH, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02963272
- Sponsor's protocol ID
- RECHMPL16_0194
- Other IDs
- 2016-A01148-43
- Acronym
- STADE-HF
- Status last verified
- Oct 2021
- First submitted
- 31 Oct 2016
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huet F, Dupuy AM, Duflos C, Reis CA, Kuster N, Aguilhon S, Cristol JP, Roubille F. Soluble urokinase-type plasminogen activator receptor strongly predicts global mortality in acute heart failure patients: insight from the STADE-HF registry. Future Sci OA. 2021 Mar 29;7(5):FSO697. doi: 10.2144/fsoa-2020-0197.
PubMed 34046195Huet F, Nicoleau J, Dupuy AM, Curinier C, Breuker C, Castet-Nicolas A, Lotierzo M, Kalmanovich E, Zerkowski L, Akodad M, Adda J, Agullo A, Leclercq F, Pasquie JL, Battistella P, Roubille C, Fesler P, Mercier G, Bourel G, Cristol JP, Roubille F. STADE-HF (sST2 As a help for management of HF): a pilot study. ESC Heart Fail. 2020 Apr;7(2):774-778. doi: 10.1002/ehf2.12663. Epub 2020 Mar 13.
PubMed 32168423
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of ST2 to Diagnosis and Management of Patients With Heart Failure (HF)
- ClinicalTrials.gov ID
- NCT02963272
- Acronym / sponsor ID
- STADE-HF / RECHMPL16_0194
- Keywords
- Heart failure, ST2, fibrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 19 Jan 2017 (actual)
- Primary completion
- 26 Apr 2019 (actual)
- Study completion
- 26 Apr 2019 (actual)
- First posted
- 15 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional strategy | Other | Other: Conventional strategyConventional strategy to manage the patients with HF, following the international guidelines |
| ST2-guided strategy | Other | Other: ST2-guided strategyManagement of patients follow the international guidelines but are also guided by the ST2, to adapt the drugs indicated in patients with HF. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Heart failure hospitalization
Key exclusion criteria (4 listed)
- Other study
- Pregnancy, feeding
- Refusal
- Not possible to perform information
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional strategyConventional strategy to manage the patients with HF, following the international guidelines. | Other | Conventional strategy |
| ST2-guided strategypatients wit ST2 over the median are targeted with higher doses of drugs with putative effects on fibrosis and anti HF pathophysiology | Other | ST2-guided strategy |
Primary outcome
Rehospitalization
Time frame: 1 month
The frequence of the rehospitalization of the patient according to the treatment received
7 secondary outcomes
Economic evaluation
Time frame: 1 month and 1 year
Mortality
Time frame: 1 month and 1 year
Biological markers of HF Assay
Time frame: 1 month and 1 year
Stay at hospital duration
Time frame: 1 month and 1 year
Markers of the renal function assay
Time frame: 1 month and 1 year
Rehospitalization for heart failure
Time frame: 1 month and 1 year
Rehospitalization for all causes
Time frame: 1 month and 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Results publication: PubMed 34046195Huet F, Dupuy AM, Duflos C, Reis CA, Kuster N, Aguilhon S, Cristol JP, Roubille F. Soluble urokinase-type plasminogen activator receptor strongly predicts global mortality in acute heart failure patients: insight from the STADE-HF registry. Future Sci OA. 2021 Mar 29;7(5):FSO697. doi: 10.2144/fsoa-2020-0197.
- Results publication: PubMed 32168423Huet F, Nicoleau J, Dupuy AM, Curinier C, Breuker C, Castet-Nicolas A, Lotierzo M, Kalmanovich E, Zerkowski L, Akodad M, Adda J, Agullo A, Leclercq F, Pasquie JL, Battistella P, Roubille C, Fesler P, Mercier G, Bourel G, Cristol JP, Roubille F. STADE-HF (sST2 As a help for management of HF): a pilot study. ESC Heart Fail. 2020 Apr;7(2):774-778. doi: 10.1002/ehf2.12663. Epub 2020 Mar 13.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François ROUBILLE, PU-PH principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional strategy and ST2-guided strategy in people with Heart Failure and Diastolic Heart Failure, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rehospitalization (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02963272, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.