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AI-Powered trial asks: does adding a second drug cut heart failure risk?

NCT ID NCT07719621

Knowledge-focused Sponsor: Aeterna Medical Solutions SL 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 22, 2026 · Last updated Aug 20, 2026 · Updated 3 times

Summary

This study uses computer simulations to compare two treatment strategies for people with chronic kidney disease and type 2 diabetes. Researchers will model whether adding empagliflozin to finerenone reduces heart failure, hospitalizations, and cardiovascular death more than finerenone alone. No human participants are involved — artificial intelligence recreates a large virtual population based on real clinical data.

What this could mean

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

Active substance
a combination of finerenone and empagliflozin
What this could lead to
If the combination outperforms finerenone alone, it could point to a more effective treatment strategy for preventing heart failure in people with kidney disease and diabetes.
What could go wrong
This is a computer simulation, not a real-patient trial, so results may not fully reflect real-world outcomes. The findings depend on the accuracy of the underlying data and assumptions.

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

About 50,000 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Nov 2026

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

A massive synthetic cohort (N = 50,000 to 100,000 virtual subjects) will be structured and parameterized to faithfully reproduce the characteristics of the reference population, using a four-phase instantiation framework designed to ensure biological plausibility. Each virtual patient will be cloned to experience both treatment trajectories simultaneously, acting as their own absolute control and eliminating inter-individual variability bias.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: The same characteristics of the reference population: CONFIDENCE trial (NCT05254002). In brief: * Patients with chronic kidney disease (eGFR 30-90 ml/min/1.73 m²) * Persistent albuminuria (UACR 100-5000 mg/g) * Type 2 diabetes mellitus (T2D) under stable blockade of the renin-angiotensin system (ACEi/ARB) Exclusion Criteria: The same characteristics of the reference population: CONFIDENCE trial (NCT05254002). In brief: * Participants with type 1 diabetes (T1D). * Participant with hepatic insufficiency classified as Child-Pugh C. * Participants currently treated or who were treated with Finerenone (Kerendia©) within 8 weeks prior to the screening visit.

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Conditions

The condition(s) this trial relates to.

chronic kidney disease chronic renal failure syndrome type 2 diabetes mellitus

As listed by the trial registrant

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

CKD - chronic kidney disease Diabetes mellitus, type 2

How to take part

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

  1. 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 ↗

  2. 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.

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