BIOmarker Based Diagnostic TOOLkit to Personalise Pharmacological Approaches in Congestive Heart … (NCT07635810) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
BIOmarker Based Diagnostic TOOLkit to Personalise Pharmacological Approaches in Congestive Heart Failure: the BIOTOOL-CHF Validation Trial
Italy600 participantsStarted 2026-07-15
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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:
Exclusion criteria
. Acute coronary syndrome or cerebrovascular accident in the previous 30 days
. Clinical congestion score greater or equal to 5 at the time of randomization
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is described as 'not yet recruiting' — do you know when it's expected to open, and would it make sense for me to revisit this option once enrollment actually begins?
2The trial measures a combination of death, heart failure events, and changes in how I feel day-to-day over just 3 months — does that short follow-up period mean we'd learn relatively quickly whether the biomarker-guided approach is helping me, or does it limit what we'd actually find out about longer-term outcomes?
3Since this study is focused on using biomarkers to personalize which heart failure medications I receive, how does that compare to the standard way you'd currently choose my treatment — and is there a meaningful benefit to the biomarker-guided approach at this stage of the research?
4The trial is listed as Phase 'NA,' which suggests it may be a diagnostic or validation study rather than a traditional drug trial — can you explain what that means for my safety and what risks, if any, I'd actually be taking on by participating?
5Given that this study is still not yet recruiting and the treatment approach being tested would be tailored based on my specific biomarker profile, would you be able to tell me whether my current test results would even make me a plausible candidate to discuss with the research team when the trial opens?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Win Ratio of Participants in Hierarchical Composite Endpoint (All-Cause Death, Heart Failure Events, and KCCQ-TSS Change) at 3 Months
Timeframe: 3 months
Trial details
NCT IDNCT07635810
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna
. 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
. Active myocarditis
. Patients with any wearable or implantable device for congestion monitoring which is actively used to guide clinical practice
. Patients with left ventricular assist device (LVAD)/ biventricular assist device (Bi-VAD) or heart transplantation