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

NCT07635810 · tracked via the Priya Life Science Italy tracker

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Phase

Not applicable

Started

2026-12-15

Last updated

2026-08-31

Condition(s) studied

Congestive Heart Failure(CHF)

Investigational drug(s) / intervention(s)

Intervention: diuretic therapy guided by the Biological Congestion Score (BCS) using a predefined treatment nomogram

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.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

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

Trial sites (1)

Facility	City	Region	Status
IRCCS Azienda Ospedaliero-Universitaria di Bologna	Bologna	Bologna

More IRCCS Azienda Ospedaliero-Universitaria di Bologna trials in Italy

Radiological Diagnostics in Patients With Deep Endometriosis Recruiting

Antimicrobial Combination Therapy for Treatment of Enterococcus Faecalis Bacteremia Recruiting

An Italian Multicentric Retrospective Observational Study to Assess Effectiveness and Safety of the Combination of Tafasitamab and Lenalidomide in Diffuse Large B-cell Lymphoma Patients Treated Under Named Patient Program Recruiting

Phenotypic and Genotypic Characterisation of a Large, Multicentre Italian Cohort of 46, XY DSD Patients Recruiting

Multi-Dimensional Genomic Dissection of Ring Chromosome 14 Syndrome Active, not recruiting

Other trials for the same condition

BIOmarker Based Diagnostic TOOLkit to Personalize Pharmacological Approaches in Congestive Heart Failure Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07635810 on ClinicalTrials.gov ↗ ← All trials in Italy