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AI tool aims to tailor diuretic doses for heart failure patients

NCT ID NCT07470554

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study analyzes data from over 4,200 heart failure patients to create a tool that uses biomarkers to guide diuretic dosing. Researchers aim to develop a machine-learning algorithm that could personalize treatment and improve outcomes. The study is observational and does not test a new drug or intervention.

What this could mean

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

What this could lead to
If successful, this could lead to a machine-learning algorithm that helps doctors choose the right diuretic dose for each heart failure patient, potentially reducing hospitalizations and deaths.
What could go wrong
This is a retrospective study using existing data, not a new treatment trial. The algorithm needs to be tested in future prospective studies before it can be used in practice.

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.

Participants

4,254 people

The number who actually took part.

Started

Dec 2024

Expected to finish

Jan 2034

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.

Who is studied

The study population will be patients with congestive HF previously enrolled in the BIOSTAT-CHF cohorts. The index cohort consists of a prospectively enrolled series of 2516 patients from 69 centres in 11 European countries recruited between December 2010 and December 2012 and with a median follow-up of 21 months \[interquartile range (IQR) 15 - 27 months\]. Validation cohort was designed as well as a multicentre, prospective, observational study, which included 1738 patients from six centres in Scotland, United Kingdom

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: In order to have been included to participate in the index trial, a subject must have met all of the following criteria: * age \>=18 years with symptoms of new-onset or worsening heart failure; * objective evidence of cardiac dysfunction documented either by left ventricular ejection fraction \<=40% or plasma concentrations of brain natriuretic peptide (BNP) \>400 pg/mL and/or NT-proBNP \>2000 pg/mL; * treatment with either oral or intravenous furosemide \>=40 mg/day or equivalent at the time of inclusion; not previously treated with evidence-based therapies (angiotensin-converting enzyme inhibitors or angiotensin receptor blockers and beta-blockers) or receiving \<=50% of target doses of these drugs at the time of inclusion; anticipated initiation or up-titration of ACE inhibitors or ARBs and/or beta-blockers by the treating physician. For the validation cohort, patients had to fulfil the following inclusion criteria: * age \>=18 years; * diagnosis of heart failure with a previous documented admission requiring diuretic treatment; * treatment with furosemide \>=20 mg/day or equivalent; * not previously treated or receiving \<=50% of target doses of ACE inhibitors or ARBs and/or beta-blockers; * anticipated initiation or up-titration of ACE inhibitors or ARBs and/or beta-blockers. In both trials, patients could be enrolled as inpatients or from outpatient clinics. Exclusion Criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: \- known diagnosis of septicaemia, known diagnosis of acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy, heart transplant recipient or admitted for cardiac transplantation or left ventricular assist device surgery, anticipated need for surgery or any cardiovascular intervention, except implantable cardioverter defibrillator and-or cardiac resynchronization therapy, within 4 weeks, current known inability to follow instructions or comply with follow-up procedures, and treatment with medications or devices not approved in Europe. Patients with concomitant pulmonary disease, even if severe, valvular disease, acute coronary syndrome or stroke, could be included when the primary diagnosis for admission to hospital or outpatient clinic visit was heart failure, rather than the concomitant condition

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Heart Failure and Transplant Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna

    Bologna, Emilia-Romagna, 40138, Italy

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