NCT02963272

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 15, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

January 19, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2019

Completed
Last Updated

September 30, 2025

Status Verified

October 1, 2021

Enrollment Period

2.3 years

First QC Date

October 31, 2016

Last Update Submit

September 24, 2025

Conditions

Keywords

Heart failureST2fibrosis

Outcome Measures

Primary Outcomes (1)

  • Rehospitalization

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

    1 month

Secondary Outcomes (7)

  • Economic evaluation

    1 month and 1 year

  • Mortality

    1 month and 1 year

  • Biological markers of HF Assay

    1 month and 1 year

  • Stay at hospital duration

    1 month and 1 year

  • Markers of the renal function assay

    1 month and 1 year

  • +2 more secondary outcomes

Study Arms (2)

Conventional strategy

OTHER

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

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.

Other: ST2-guided strategy

Interventions

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

Conventional strategy

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

ST2-guided strategy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Heart failure hospitalization

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Regional Hospital Arnaud de Villeneuve

Montpellier, Languedoc-Roussillon, 34295, France

Location

MeSH Terms

Conditions

Heart FailureHeart Failure, DiastolicFibrosis

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • François ROUBILLE, PU-PH

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2016

First Posted

November 15, 2016

Study Start

January 19, 2017

Primary Completion

April 26, 2019

Study Completion

April 26, 2019

Last Updated

September 30, 2025

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations