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BIOmarker Based Diagnostic TOOLkit to Personalise Pharmacological Approaches in Congestive Heart Failure: the BIOTOOL-CHF Validation Trial

27 août 2026 mis à jour par: IRCCS Azienda Ospedaliero-Universitaria di Bologna
By the re-analysis, in the BIOTOOL-CHF DISCO study, of a previously enrolled cohort of patients, a Biological Congestion Score (BCS) was newly developed. The BCS integrates four congestion-related biomarkers with key clinical variables. The BIOTOOL-CHF VALID trial is designed to prospectively evaluate whether a BCS-assisted strategy for diuretic management improves clinical outcomes and quality of life in patients with chronic Heart Failure (HF) compared with standard care.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

This prospective randomised study is part of a wider project that has been funded within the Horizon program by the call HORIZON-HLTH-2022-TOOL-11-01, project # 101095653, BIOTOOL-CHF. Herein the study will compare the outcomes of patients with chronic HF managed according to current usual clinical practice vs. patients in which therapy will be managed following the calculation of the BCS. In the BIOTOOL-CHF DISCO study, the BCS showed high accuracy in detecting congestion and better performance than clinical assessment in predicting outcomes, so it was hypothesized that, by providing a more accurate estimate of congestion in patients with chronic heart failure, the BCS may assist clinicians in managing diuretic therapy more accurately than the usual clinical assessment. The primary objective will be the comparison of standard-of-care management of chronic heart failure with a BCS-assisted strategy for guiding diuretic therapy, assessing the impact on a hierarchical composite clinical outcome at 3 months.

Type d'étude

Interventionnel

Inscription (Estimé)

600

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Italie
    • Bologna
      • Bologna, Bologna, Italie, 40138
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Inclusion criteria:

  1. Adult patients with symptomatic chronic heart failure diagnosed at least 3 months prior to randomization
  2. Treatment with at least 40 mg of oral furosemide or equivalent at the time of enrolment to control symptoms

  3. At least one of the following:

    • At discharge from hospitalization for heart failure
    • History of hospitalization for heart failure in the previous 3 months
    • History of treatment with intravenous diuretics or inotropes in ambulatory setting in the previous 3 months
    • B-type Natriuretic Peptide (BNP) > 400 pg/ml or N-terminal pro-B-type natriuretic peptide (NT-proBNP) > 1000 pg/ml if in sinus rhythm or BNP > 800 pg/ml or NT-proBNP > 2000 pg/ml if in atrial fibrillation (AF) assessed within 4 weeks before enrolment

Exclusion criteria:

  1. Acute coronary syndrome or cerebrovascular accident in the previous 30 days
  2. Acute heart failure requiring immediate hospitalization or intravenous therapy (acute pulmonary edema, cardiogenic shock, arrhythmic storm)
  3. Clinical congestion score greater or equal to 5 at the time of randomization
  4. Any cardiovascular intervention (cardiac surgery/coronary revascularization (Coronary Artery Bypass Grafting (CABG) or Percutaneous Coronary Intervention (PCI))/ Cardiac Resynchronization Therapy (CRT) implant, percutaneous treatment of valve disease, arrhythmias ablation) performed in the previous 3 months or planned in the following 3 months
  5. Active myocarditis
  6. Patients with any wearable or implantable device for congestion monitoring which is actively used to guide clinical practice
  7. Patients with left ventricular assist device (LVAD)/ biventricular assist device (Bi-VAD) or heart transplantation
  8. Severe stenotic valvular disease
  9. Glomerular Filtration Rate (GFR) <15 ml/min (estimated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)) or dialysis (hemodialysis or peritoneal dialysis)
  10. Liver cirrhosis with ascites
  11. Significant cognitive impairment
  12. Pregnancy or planned pregnancy during the study period
  13. Active malignancy or severe hematological disorders

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Groupe d'intervention
Autre: Intervention: diuretic therapy guided by the Biological Congestion Score (BCS) using a predefined treatment nomogram
In patients randomized to the intervention arm, clinical variables and biomarker results will be entered into the score calculator. The calculator will provide to the clinician an estimate of the degree of congestion by the BCS, and the probability of cardiovascular hospitalization or death within the subsequent 3 months. Discrepancies will be recorded in the electronic Case Report Form (eCRF). Final decisions and eventual therapy adjustments will remain at the discretion of the caring physicians.
Aucune intervention: Groupe de contrôle

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Win Ratio of Participants in Hierarchical Composite Endpoint (All-Cause Death, Heart Failure Events, and KCCQ-TSS Change) at 3 Months
Délai: 3 months

Title: Win Ratio of Hierarchical Composite Endpoint (All-Cause Death, Heart Failure Events, and Change in KCCQ-TSS) at 3 Months Description: To compare BCS-guided management vs. standard of care in chronic heart failure. The hierarchical composite endpoint is assessed using the win ratio method, combining in priority order: (1) time to all-cause death (days), (2) number of heart failure events (HF hospitalizations, emergency visits, or unplanned parenteral HF therapy; count), and (3) change from baseline in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS; range 0-100 points, higher scores indicate better health status). The three components are combined into a single win ratio value via the hierarchical win ratio method; no separate unit applies to each component independently.

Unit of Measure: Win Ratio
3 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Time to All-Cause Death
Délai: 3 months
Time from randomization to death from any cause. Unit of Measure: Days
3 months
Number of Heart Failure Events per Participant
Délai: 3 months

Number of heart failure events per participant, including HF hospitalizations, emergency department visits for heart failure, and unplanned parenteral HF therapy.

Unit of Measure: Number of events
3 months
Change from Baseline in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS)
Délai: Baseline and 3 months

Change from baseline to 3 months in KCCQ-TSS. Scale range: 0 to 100 points; higher scores indicate better health status.

Unit of Measure: Points
Baseline and 3 months
Percent Change from Baseline in Serum CA-125
Délai: Baseline and 3 months
Percent change from baseline to 3 months in serum CA-125, measured in U/mL. Unit of Measure: Percent change
Baseline and 3 months
Percent Change from Baseline in Serum NT-proBNP
Délai: Baseline and 3 months

Percent change from baseline to 3 months in serum N-terminal pro-B-type natriuretic peptide (NT-proBNP), measured in pg/mL.

Unit of Measure: Percent change
Baseline and 3 months
Number of Participants with Dyskalemia
Délai: 3 months

Number of participants with at least one occurrence of dyskalemia, defined as serum potassium below 3.5 mEq/L or above 5.0 mEq/L at any time point.

Unit of Measure: Number of Participants
3 months
Number of Participants Receiving at Least 50% of Target GDMT Doses
Délai: 3 months

Number of participants receiving at least 50% of the target dose for all prescribed Guideline-Directed Medical Therapy (GDMT) classes at 3 months.

Unit of Measure: Number of Participants
3 months
Percent Change from Baseline in Bio-Adrenomedullin (Bio-ADM) Plasma Concentration
Délai: Baseline and 3 months
Percent change from baseline to 3 months in plasma Bio-Adrenomedullin (bio-ADM), measured in pmol/L. Unit of Measure: Percent change
Baseline and 3 months
Number of Participants Receiving All Recommended GDMT Classes
Délai: 3 months

Number of participants on all recommended Guideline-Directed Medical Therapy (GDMT) classes at 3 months: all 4 pillars for Heart Failure with Reduced Ejection Fraction (HFrEF) (Renin-Angiotensin-Aldosterone System (RAAS) inhibitor or Angiotensin Receptor-Neprilysin Inhibitor (ARNI), beta-blocker, Mineralocorticoid Receptor Antagonist (MRA), Sodium-Glucose Cotransporter-2 (SGLT2) inhibitor); SGLT2 inhibitor for Heart Failure with Mildly Reduced Ejection Fraction (HFmrEF)/Heart Failure with Preserved Ejection Fraction (HFpEF).

Unit of Measure: Number of Participants
3 months
Number of Participants with Ventricular Arrhythmia Leading to Implantable Cardioverter-Defibrillator (ICD) Intervention
Délai: 3 months

Number of participants with ventricular arrhythmia leading to Implantable Cardioverter-Defibrillator (ICD) therapy, including anti-tachycardia pacing or shock, during the study period.

Unit of Measure: Number of Participants
3 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Collaborateurs

European Commission
European Clinical Research Infrastructure Network

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

15 décembre 2026

Achèvement primaire (Estimé)

6 septembre 2027

Achèvement de l'étude (Estimé)

4 décembre 2028

Dates d'inscription aux études

Première soumission

10 mars 2026

Première soumission répondant aux critères de contrôle qualité

3 juin 2026

Première publication (Réel)

9 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

31 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

27 août 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • BIOTOOL-CHF VALID
  • 101095653 (Autre subvention/numéro de financement: European Health and Digital Executive Agency)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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