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.
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 discharge from hospitalization for heart failure
History of hospitalization for heart failure in the previous 3 months
Acute coronary syndrome or cerebrovascular accident in the previous 30 days
Acute heart failure requiring immediate hospitalization or intravenous therapy (acute pulmonary edema, cardiogenic shock, arrhythmic storm)
Clinical congestion score greater or equal to 5 at the time of randomization
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