NCT07635810Not yet recruiting
BIOmarker Based Diagnostic TOOLkit to Personalise Pharmacological Approaches in Congestive Heart Failure: the BIOTOOL-CHF Validation Trial
Source: ClinicalTrials.gov · Last updated 31 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 600 (estimated)
- First submitted
- 10 Mar 2026
- Start date
- 15 Dec 2026
- Primary completion date
- 6 Sept 2027
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Diseases
- Heart failure
- NCT number
- NCT07635810
What you commit to
- Study type: Interventional
- Planned participants: 600
- From 15 Dec 2026 to the primary completion date, 6 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Lab values
- Glomerular Filtration Rate (GFR) \<15 ml/min (estimated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)) or dialysis (hemodialysis or peritoneal dialysis)
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS Azienda Ospedaliero-Universitaria di Bologna Coordinator of this site? Confirm its status | Bologna | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.