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AI heart failure trial pulled before starting

NCT ID NCT07369141

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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This trial aimed to see if an AI program could help doctors choose better heart failure treatments for each patient. It planned to compare standard care with AI-generated treatment advice. However, the study was withdrawn before enrolling any participants, so no results are available.

What this could mean

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

Active substance
AI-derived biomarker-guided treatment algorithm

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.

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Jun 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. Provide written and dated informed consent for participation prior to trial admission, 2. Age ≥18 years, female or male 3. Diagnosis of heart failure\* either before discharge of a heart failure hospital admission or in the outpatient setting, 4. Symptomatic, defined as NYHA class II - IV, 5. LVEF \< 50% measured in the last 12 months (using any modality), with no occurrence of HF event(s) since that measurement) and 6. Those not previously treated with evidence-based therapies or sub-optimally treated with GDMT defined as; • Not treated with one of the foundational four\*\* HF medication unless absolute contraindication or documented intolerance * Definition of heart failure according to the most recent Heart Failure Guidelines of the European Society of Cardiology * Foundational four heart failure medication: BBs, ARNi, MRAs and SGLT2i. NB. This does not include ACE and ARBs these are permitted. Exclusion Criteria: 1. Inability to understand and sign informed consent, 2. Scheduled or on renal replacement therapy, 3. Clearly documented intolerance to BBs, ARNI, SGLT2i or MRAs 4. Diagnosis of acute myocarditis or (non)obstructive hypertrophic cardiomyopathy, 5. The presence of a mechanical assist device, 6. Scheduled for mechanical assist device or heart transplant, 7. Acute coronary syndrome (ACS) in the past 3 months or current angina pectoris ≥class III, 8. Requiring valvular surgery or revascularization in the upcoming 3 months or revascularization within the past 3 months, 9. Anticipated need for surgery or any cardiovascular intervention, except implantable cardioverter defibrillator and/or cardiac resynchronization therapy, within 4 weeks, 10. Other non-cardiac conditions with limited life expectancy (≤ duration of the trial/ 1 year), 11. Participation in another (intervention) clinical trial (registry studies not included) until the onsite EoS visit (V5) at 9 months has been completed. 12. Women who are pregnant, breastfeeding or may be considering pregnancy during the study duration.

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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

  • Erasmus Medical Center

    Rotterdam, Netherlands

  • Leiden University Medical Center

    Leiden, Netherlands

  • Maastricht University Medical Center

    Maastricht, Netherlands

  • University Medical Center Groningen

    Groningen, Netherlands

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