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New blood test score could personalize heart failure diuretic use

NCT ID NCT07635810

Disease control Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 01, 2026 · Updated 3 times

Summary

This trial tests whether a new scoring system, called the Biological Congestion Score (BCS), can help doctors better manage diuretic medications in people with chronic heart failure. The BCS combines four blood biomarkers with clinical information to estimate fluid congestion and risk. Researchers will compare outcomes like death, heart failure events, and quality of life between patients whose diuretic therapy is guided by the BCS and those receiving standard care. The study plans to enroll 600 adults with symptomatic heart failure who are already taking diuretics.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
diuretic therapy guided by the Biological Congestion Score (BCS)
What this could lead to
If successful, this could provide a more personalized way to manage fluid buildup in heart failure patients, potentially reducing hospitalizations and improving quality of life.
What could go wrong
This is a validation trial, not a treatment itself, so it may not show clear benefits. The score is based on biomarkers that may not work for all patients, and the study is not yet recruiting.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 600 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: 1. Adult patients with symptomatic chronic heart failure diagnosed at least 3 months prior to randomization 2. Treatment with at least 40 mg of oral furosemide or equivalent at the time of enrolment to control symptoms 3. 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 Exclusion criteria: 1. Acute coronary syndrome or cerebrovascular accident in the previous 30 days 2. Acute heart failure requiring immediate hospitalization or intravenous therapy (acute pulmonary edema, cardiogenic shock, arrhythmic storm) 3. Clinical congestion score greater or equal to 5 at the time of randomization 4. 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 5. Active myocarditis 6. Patients with any wearable or implantable device for congestion monitoring which is actively used to guide clinical practice 7. Patients with left ventricular assist device (LVAD)/ biventricular assist device (Bi-VAD) or heart transplantation 8. Severe stenotic valvular disease 9. Glomerular Filtration Rate (GFR) \<15 ml/min (estimated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)) or dialysis (hemodialysis or peritoneal dialysis) 10. Liver cirrhosis with ascites 11. Significant cognitive impairment 12. Pregnancy or planned pregnancy during the study period 13. Active malignancy or severe hematological disorders

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Conditions

The condition(s) this trial relates to.

congestive heart failure heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Congestive heart failure(CHF)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    Bologna, Bologna, 40138, Italy

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Other studies related to the condition(s) this trial covers.