AI tool aims to tailor diuretic doses for heart failure patients
NCT ID NCT07470554
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.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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4,254 people
The number who actually took part.
- Started
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Dec 2024
- Expected to finish
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Jan 2034
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Heart Failure and Transplant Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Emilia-Romagna, 40138, Italy
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