Using a biomarker to guide treatment in patients with acute heart failure
Medico-economic Evaluation of Therapeutic Adaptation Guided by the Soluble Suppression of Tumorigenicity 2 (sST-2) Biomarker in the Management of Patients With Acute Heart Failure
NA · University Hospital, Montpellier · NCT04554277
This study is testing if using a specific blood marker to guide treatment can help people with acute heart failure feel better and improve their quality of life.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 710 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Montpellier (other) |
| Locations | 12 sites (Montpellier, Occitanie and 11 other locations) |
| Trial ID | NCT04554277 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of using the soluble suppression of tumorigenicity 2 (sST2) biomarker to guide the management of patients with acute heart failure. It is a multicentric, blinded, prospective randomized controlled trial involving 710 patients across 10 centers over a 12-month recruitment period, with a follow-up of 24 months. Participants will be randomized into two groups: one receiving usual treatment without knowledge of sST2 levels and the other receiving treatment guided by known sST2 levels. The primary endpoint is the Quality Adjusted Life Years (QALY), while secondary endpoints include cost-efficacy ratios and readmission rates.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have been hospitalized for heart failure and meet specific biomarker criteria.
Not a fit: Patients awaiting heart transplantation or those with severe hemodynamic instability may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce hospital readmissions and improve the quality of life for patients with heart failure.
How similar studies have performed: Other studies have shown promise in using biomarkers for guiding therapy in heart failure, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * 18 years or older * Hospitalization for heart failure (NTproBNP(N-terminal pro-Brain Natriuretic Peptid) ≥450 pg/ml (ou BNP ≥400 pg/ml) Exclusion criteria: * 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
Where this trial is running
Montpellier, Occitanie and 11 other locations
- Lapeyronie Hospital — Montpellier, Occitanie, 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)
Study contacts
- Study coordinator: Jean-Paul CRISTOL, MD, PhD
- Email: jp-cristol@chu-montpellier.fr
- Phone: (0)4 67 33 83 14
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heart Failure, Heart failure, Biomarker, Guided therapy