[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641862":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":11,"centralContacts":22,"locations":28,"responsibleParty":40,"collaborators":11,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":11,"eligibilityCriteria":47,"healthyVolunteers":44,"sex":48,"minAge":49,"maxAge":11,"enrollmentInfo":50,"targetDuration":11,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":63,"whyStopped":11,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},{"fullName":5,"class":6},"IRCCS Azienda Ospedaliero-Universitaria di Bologna","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention Group","EXPERIMENTAL",null,[13],"Other: Intervention: diuretic therapy guided by the Biological Congestion Score (BCS) using a predefined treatment nomogram",{"label":15,"type":16,"description":11,"interventionNames":11},"Control Group","NO_INTERVENTION",[18],{"type":6,"name":19,"description":20,"armGroupLabels":21,"otherNames":11},"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.",[9],[23],{"name":24,"role":25,"phone":26,"phoneExt":11,"email":27},"Luciano Potena","CONTACT","(+39) 0512143725","luciano.potena2@unibo.it",[29],{"facility":5,"status":11,"city":30,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":11},"Bologna","40138","Italy","IT",{"type":35,"coordinates":36},"Point",[37,38],11.33875,44.49381,{"lat":38,"lon":37},{"type":41,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100641862","biomarker-based-diagnostic-toolkit-to-personalise-pharmacological-approaches-in-congestive-heart-failure-the-biotool-chf-validation-trial-100641862",false,"NCT07635810","BIOmarker Based Diagnostic TOOLkit to Personalise Pharmacological Approaches in Congestive Heart Failure: the BIOTOOL-CHF Validation Trial","Inclusion criteria:\n\n1. Adult patients with symptomatic chronic heart failure diagnosed at least 3 months prior to randomization\n2. Treatment with at least 40 mg of oral furosemide or equivalent at the time of enrolment to control symptoms\n3. At least one of the following:\n\n   * At discharge from hospitalization for heart failure\n   * History of hospitalization for heart failure in the previous 3 months\n   * History of treatment with intravenous diuretics or inotropes in ambulatory setting in the previous 3 months\n   * B-type Natriuretic Peptide (BNP) \\> 400 pg\u002Fml or N-terminal pro-B-type natriuretic peptide (NT-proBNP) \\> 1000 pg\u002Fml if in sinus rhythm or BNP \\> 800 pg\u002Fml or NT-proBNP \\> 2000 pg\u002Fml if in atrial fibrillation (AF) assessed within 4 weeks before enrolment\n\nExclusion criteria:\n\n1. Acute coronary syndrome or cerebrovascular accident in the previous 30 days\n2. Acute heart failure requiring immediate hospitalization or intravenous therapy (acute pulmonary edema, cardiogenic shock, arrhythmic storm)\n3. Clinical congestion score greater or equal to 5 at the time of randomization\n4. Any cardiovascular intervention (cardiac surgery\u002Fcoronary revascularization (Coronary Artery Bypass Grafting (CABG) or Percutaneous Coronary Intervention (PCI))\u002F 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\n5. Active myocarditis\n6. Patients with any wearable or implantable device for congestion monitoring which is actively used to guide clinical practice\n7. Patients with left ventricular assist device (LVAD)\u002F biventricular assist device (Bi-VAD) or heart transplantation\n8. Severe stenotic valvular disease\n9. Glomerular Filtration Rate (GFR) \\\u003C15 ml\u002Fmin (estimated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)) or dialysis (hemodialysis or peritoneal dialysis)\n10. Liver cirrhosis with ascites\n11. Significant cognitive impairment\n12. Pregnancy or planned pregnancy during the study period\n13. Active malignancy or severe hematological disorders","ALL","18 Years",{"count":51,"type":52},600,"ESTIMATED","INTERVENTIONAL",[55],"NA","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.",[58],"Congestive Heart Failure(CHF)",[60,61,62],"Congestion","Biomarkers","Heart failure","NOT_YET_RECRUITING","2026-06-10",{"date":66,"type":67},"2026-06-12","ACTUAL",{"date":69,"type":52},"2026-07-15",{"date":71,"type":52},"2028-12-04",{"name":5,"class":6},1]