Biomarker score to guide water pill treatment in chronic heart failure
Tests a biomarker score for guiding diuretic dosing in adults with chronic heart failure.
Plain-language title generated from the registry record
Registry title: BIOmarker Based Diagnostic TOOLkit to Personalise Pharmacological Approaches in Congestive Heart Failure: the BIOTOOL-CHF Validation Trial
Key facts
- Where
- Bologna, ItalySee the site
Where in Italy
- IRCCS Azienda Ospedaliero-Universitaria di BolognaBologna, ItalyNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Trial code
- NCT07635810
- Record updated
- 31 August 2026
- Original description
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.Read full original descriptionShow less
BIOmarker Based Diagnostic TOOLkit to Personalise Pharmacological Approaches in Congestive Heart Failure: the BIOTOOL-CHF Validation Trial
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.
Inclusion: Adult patients with symptomatic chronic heart failure diagnosed at least 3 months prior to randomization; Treatment with at least 40 mg of oral furosemide or equivalent at the time of enrolment to control symptoms; 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: Acute coronary syndrome or cerebrovascular accident in the previous 30 days; 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; Acute heart failure requiring immediate hospitalization or intravenous therapy (acute pulmonary edema, cardiogenic shock, arrhythmic storm); Patients with left ventricular assist device (LVAD)/ biventricular assist device (Bi-VAD) or heart transplantation; Severe stenotic valvular disease; Significant cognitive impairment; Active malignancy or severe hematological disorders; Glomerular Filtration Rate (GFR) <15 ml/min (estimated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)) or dialysis (hemodialysis or peritoneal dialysis); Clinical congestion score greater or equal to 5 at the time of randomization; Active myocarditis; Patients with any wearable or implantable device for congestion monitoring which is actively used to guide clinical practice; Liver cirrhosis with ascites; Pregnancy or planned pregnancy during the study period.