NCT04554277

Brief Summary

Management of patients with heart Failure remains a major health concern because of the high rate of rehospitalization, mortality and induced-cost. Biomarkers could help to guide the management of patients with heart failure (HF). Soluble suppression of tumorigenicity 2 (sST2) appears as a promising biomarker. As a working hypothesis, we postulate that sST2 values monitoring could be an helpful guide for medical management in an attempt to reduce hospital readmission.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
710

participants targeted

Target at P75+ for not_applicable heart-failure

Timeline
7mo left

Started Apr 2021

Longer than P75 for not_applicable heart-failure

Geographic Reach
1 country

12 active sites

Status
recruiting

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

Study Progress89%
Apr 2021Jan 2027

First Submitted

Initial submission to the registry

September 14, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 18, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

April 27, 2021

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2026

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Expected
Last Updated

September 30, 2025

Status Verified

May 1, 2025

Enrollment Period

5 years

First QC Date

September 14, 2020

Last Update Submit

September 24, 2025

Conditions

Heart Failure

Keywords

Heart failureBiomarkerGuided therapy

Outcome Measures

Primary Outcomes (1)

  • Cost-utility ratio

    Cost will be compared between guided therapy using sST-2 levels and usual group. Utility will be derived from the French EQ5D (EuroQol 5 Dimensions), measured at 24 months. QALY (Quality Adjusted Life Years).

    2 years

Secondary Outcomes (4)

  • Cost-efficacy ratio

    2 years

  • Cost of initial hospitalisation and rehospitalisation

    2 years

  • Number of hospitalisation for heart failure

    30 days

  • Number of hospitalisation for heart failure

    2 years

Study Arms (2)

Control

NO INTERVENTION

Usual management of heart failure. The sST-2 level will be blunted.

Biomarker guided therapy

EXPERIMENTAL

Guided therapy using sST-2 monitoring at the discharge from initial hospitalisation, 6, 12, 18 and 24 months of following.

Biological: Biomarker guided therapy

Interventions

Biomarker guided therapyBIOLOGICAL

Guided therapy using sST-2 monitoring at the discharge from initial hospitalisation, 6, 12, 18 and 24 months of following.

Biomarker guided therapy

Eligibility Criteria

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

You may qualify if:

  • years or older
  • Hospitalization for heart failure (NTproBNP(N-terminal pro-Brain Natriuretic Peptid) ≥450 pg/ml (ou BNP ≥400 pg/ml)

You may not qualify if:

  • Waiting for heart transplantation
  • Scheduled valve surgery
  • No fluent french
  • Not able to provide informed consent
  • Hemodynamic instability
  • Poor outcome during the first week.
  • Pregnancy
  • Participating to other study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Lapeyronie Hospital

Montpellier, Occitanie, 34295, France

ACTIVE NOT RECRUITING

CHU Angers

Angers, France

RECRUITING

CHU Besançon

Besançon, France

RECRUITING

CH Béziers

Béziers, France

RECRUITING

CHU Caen

Caen, France

RECRUITING

CHU Grenoble

Grenoble, France

RECRUITING

Arnaud de Villeneuve Hospital

Montpellier, France

RECRUITING

CHU Nimes

Nîmes, France

RECRUITING

APHP Pompidou

Paris, France

NOT YET RECRUITING

CHU Rennes

Rennes, France

NOT YET RECRUITING

CHU Toulouse

Toulouse, France

RECRUITING

CHU Vannes

Vannes, France

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Central Study Contacts

Jean-Paul CRISTOL, MD, PhD

CONTACT

(0)4 67 33 83 14jp-cristol@chu-montpellier.fr

Anne-Marie GORCE DUPUY

CONTACT

(0)4 67 33 79 61am-dupuy@chu-montpellier.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Prospective
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2020

First Posted

September 18, 2020

Study Start

April 27, 2021

Primary Completion

April 27, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

September 30, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

The general goal is to make the study data available to interested researchers as well as to provide proof of transparency for the study. Data (and an accompanying data dictionary) will be de-identified and potentially further cleaned or aggregated as the investigators deem necessary to protect participant anonymity. Data will be made available to persons who address a reasonable request to the study director and fulfil the requirements stipulated by the French CNIL (Commission National Informatic Liberty).

Shared Documents
STUDY PROTOCOL
Time Frame
24 months after randomisation

Locations

FR(12)