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 HF compared with standard care.

NCT Number	NCT07635810
Lead Sponsor	IRCCS Azienda Ospedaliero-Universitaria di Bologna
Conditions	Congestive Heart Failure(CHF)
Enrollment	600 participants
Start Date	2026-07-15
Primary Completion	2027-09-06 (estimated)
Study Completion	2028-12-04 (estimated)
Updated on ClinicalTrials.gov	2026-06-09