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NCT07635810

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

Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

600

Start Date

2026-12-15

Completion Date

2028-12-04

Last Updated

2026-08-31

Healthy Volunteers

Conditions

Congestive Heart Failure(CHF)

Interventions

OTHER

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.

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

Locations (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, Italy