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

27 augustus 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

600

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Interventie Groep
Ander: 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.
Geen tussenkomst: Controlegroep

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Win Ratio of Participants in Hierarchical Composite Endpoint (All-Cause Death, Heart Failure Events, and KCCQ-TSS Change) at 3 Months
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Time to All-Cause Death
Tijdsspanne: 3 months
Time from randomization to death from any cause. Unit of Measure: Days
3 months
Number of Heart Failure Events per Participant
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Medewerkers

European Commission
European Clinical Research Infrastructure Network

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

15 december 2026

Primaire voltooiing (Geschat)

6 september 2027

Studie voltooiing (Geschat)

4 december 2028

Studieregistratiedata

Eerst ingediend

10 maart 2026

Eerst ingediend dat voldeed aan de QC-criteria

3 juni 2026

Eerst geplaatst (Werkelijk)

9 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

31 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

27 augustus 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • BIOTOOL-CHF VALID
  • 101095653 (Ander subsidie-/financieringsnummer: European Health and Digital Executive Agency)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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