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Congestive Heart Failure(CHF)NCT07635810

BIOmarker Based Diagnostic TOOLkit to Personalise Pharmacological Approaches in Congestive Heart Failure: the BIOTOOL-CHF Validation Trial

A study testing Intervention: diuretic therapy guided by the Biological Congestion Score (BCS) using a predefined treatment nomogram in people with Congestive Heart Failure(CHF), run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Congestive Heart Failure(CHF)
What is being tested?
Intervention: diuretic therapy guided by the Biological Congestion Score (BCS) using a predefined treatment nomogram
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
1 siteItaly
Study dates
15 Dec 2026to 4 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
  • Active myocarditis
  • Patients with any wearable or implantable device for congestion monitoring which is actively used to guide clinical practice
Show all 13Show fewer
  • Patients with left ventricular assist device (LVAD)/ biventricular assist device (Bi-VAD) or heart transplantation
  • Severe stenotic valvular disease
  • Glomerular Filtration Rate (GFR) <15 ml/min (estimated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)) or dialysis (hemodialysis or peritoneal dialysis)
  • Liver cirrhosis with ascites
  • Significant cognitive impairment
  • Pregnancy or planned pregnancy during the study period
  • Active malignancy or severe hematological disorders

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Luciano Potena contact

(+39) 0512143725

luciano.potena2@unibo.it

Italy1 site

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    Bologna, Bologna, 40138

Other trials in Italy

About this study

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.

Read the detailed description

This prospective randomised study is part of a wider project that has been funded within the Horizon program by the call HORIZON-HLTH-2022-TOOL-11-01, project # 101095653, BIOTOOL-CHF. Herein the study will compare the outcomes of patients with chronic HF managed according to current usual clinical practice vs. patients in which therapy will be managed following the calculation of the BCS. In the BIOTOOL-CHF DISCO study, the BCS showed high accuracy in detecting congestion and better performance than clinical assessment in predicting outcomes, so it was hypothesized that, by providing a more accurate estimate of congestion in patients with chronic heart failure, the BCS may assist clinicians in managing diuretic therapy more accurately than the usual clinical assessment. The primary objective will be the comparison of standard-of-care management of chronic heart failure with a BCS-assisted strategy for guiding diuretic therapy, assessing the impact on a hierarchical composite clinical outcome at 3 months.

Being tested
Intervention: diuretic therapy guided by the Biological Congestion Score (BCS) using a predefined treatment nomogram
Keywords
Congestion, Biomarkers, Heart failure
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intervention: diuretic therapy guided by the Biological Congestion Score (BCS) using a predefined treatment nomogramOther

    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.

Study groups in NCT07635810
Study groupRoleWhat they receive
Intervention GroupExperimentalNot described
Receives: Other: Intervention: diuretic therapy guided by the Biological Congestion Score (BCS) using a predefined treatment nomogram
Control GroupNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Win Ratio of Participants in Hierarchical Composite Endpoint (All-Cause Death, Heart Failure Events, and KCCQ-TSS Change) at 3 Months

    Title: Win Ratio of Hierarchical Composite Endpoint (All-Cause Death, Heart Failure Events, and Change in KCCQ-TSS) at 3 Months Description: To compare BCS-guided management vs. standard of care in chronic heart failure. The hierarchical composite endpoint is assessed using the win ratio method, combining in priority order: (1) time to all-cause death (days), (2) number of heart failure events (HF hospitalizations, emergency visits, or unplanned parenteral HF therapy; count), and (3) change from baseline in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS; range 0-100 points, higher scores indicate better health status). The three components are combined into a single win ratio value via the hierarchical win ratio method; no separate unit applies to each component independently.

    Unit of Measure: Win Ratio

    Measured: 3 months

Secondary outcomes (10)

  1. Time to All-Cause Death

    Time from randomization to death from any cause. Unit of Measure: Days

    Measured: 3 months

  2. Number of Heart Failure Events per Participant

    Number of heart failure events per participant, including HF hospitalizations, emergency department visits for heart failure, and unplanned parenteral HF therapy.

    Unit of Measure: Number of events

    Measured: 3 months

  3. Change from Baseline in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS)

    Change from baseline to 3 months in KCCQ-TSS. Scale range: 0 to 100 points; higher scores indicate better health status.

    Unit of Measure: Points

    Measured: Baseline and 3 months

  4. Percent Change from Baseline in Bio-Adrenomedullin (Bio-ADM) Plasma Concentration

    Percent change from baseline to 3 months in plasma Bio-Adrenomedullin (bio-ADM), measured in pmol/L. Unit of Measure: Percent change

    Measured: Baseline and 3 months

  5. Percent Change from Baseline in Serum CA-125

    Percent change from baseline to 3 months in serum CA-125, measured in U/mL. Unit of Measure: Percent change

    Measured: Baseline and 3 months

  6. Percent Change from Baseline in Serum NT-proBNP

    Percent change from baseline to 3 months in serum N-terminal pro-B-type natriuretic peptide (NT-proBNP), measured in pg/mL.

    Unit of Measure: Percent change

    Measured: Baseline and 3 months

  7. Number of Participants with Dyskalemia

    Number of participants with at least one occurrence of dyskalemia, defined as serum potassium below 3.5 mEq/L or above 5.0 mEq/L at any time point.

    Unit of Measure: Number of Participants

    Measured: 3 months

  8. Number of Participants Receiving at Least 50% of Target GDMT Doses

    Number of participants receiving at least 50% of the target dose for all prescribed Guideline-Directed Medical Therapy (GDMT) classes at 3 months.

    Unit of Measure: Number of Participants

    Measured: 3 months

  9. Number of Participants Receiving All Recommended GDMT Classes

    Number of participants on all recommended Guideline-Directed Medical Therapy (GDMT) classes at 3 months: all 4 pillars for Heart Failure with Reduced Ejection Fraction (HFrEF) (Renin-Angiotensin-Aldosterone System (RAAS) inhibitor or Angiotensin Receptor-Neprilysin Inhibitor (ARNI), beta-blocker, Mineralocorticoid Receptor Antagonist (MRA), Sodium-Glucose Cotransporter-2 (SGLT2) inhibitor); SGLT2 inhibitor for Heart Failure with Mildly Reduced Ejection Fraction (HFmrEF)/Heart Failure with Preserved Ejection Fraction (HFpEF).

    Unit of Measure: Number of Participants

    Measured: 3 months

  10. Number of Participants with Ventricular Arrhythmia Leading to Implantable Cardioverter-Defibrillator (ICD) Intervention

    Number of participants with ventricular arrhythmia leading to Implantable Cardioverter-Defibrillator (ICD) therapy, including anti-tachycardia pacing or shock, during the study period.

    Unit of Measure: Number of Participants

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2026
  2. Study start15 Dec 2026 (estimated)
  3. Primary completion6 Sep 2027 (estimated)
  4. Study completion4 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07635810
Sponsor's protocol ID
BIOTOOL-CHF VALID
Other IDs
101095653
Status last verified
May 2026
First submitted
10 Mar 2026
Last updated
31 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Intervention: diuretic therapy guided by the Biological Congestion Score (BCS) using a predefined treatment nomogram in people with Congestive Heart Failure(CHF), run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Luciano Potena ((+39) 0512143725, luciano.potena2@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Win Ratio of Participants in Hierarchical Composite Endpoint (All-Cause Death, Heart Failure Events, and KCCQ-TSS Change) at 3 Months (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07635810.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.

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