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Can 3D heart scans outperform standard ultrasound in predicting risk?

NCT ID NCT07741305

Knowledge-focused Sponsor: Istituti Clinici Scientifici Maugeri SpA Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Aug 03, 2026 · Last updated Aug 20, 2026 · Updated 3 times

Summary

This study compares two ultrasound techniques—2D and 3D speckle-tracking echocardiography—to see which measures heart muscle contraction more accurately in people with heart failure and reduced pumping function. Researchers will enroll 419 patients from seven cardiac rehabilitation hospitals in Italy, analyzing images with standardized equipment. The goal is to see how closely the two methods agree, what factors cause differences, and whether 3D imaging better predicts the risk of death than the standard 2D approach.

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 3D ultrasound proves more accurate, it could lead to better heart function assessment and more precise risk prediction for heart failure patients.
What could go wrong
This is an observational comparison, not a treatment trial. The 3D technique may not show clear advantages over the standard 2D method, and results may not change current clinical 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

About 419 people

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

Started

Jan 2026

Expected to finish

Dec 2027

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

Patients with a diagnosis of heart failure and a reduced or mildly reduced ejection fration of left ventricle

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: * Left ventricular ejection fraction (LVEF) ≤ 49%; * Echocardiographic image quality judged to be at least adequate according to a four-point visual image quality scale (good, adequate, poor, or inadequate) Exclusion Criteria: * Inability to maintain the correct position for acquiring echocardiographic images; * Arrhythmias that make multi-beat acquisition impossible (if required), such as frequent extrasystoles (supraventricular or ventricular) and atrial fibrillation; * Failure to visualize more than 2 segments of the left ventricle (LV), or inability to assess more than 3 segments during 3D GLS analysis; * Failure to sign the informed consent form and inability of the participant to understand the objectives of the study

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Conditions

The condition(s) this trial relates to.

heart failure systolic heart failure

As listed by the trial registrant

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

Heart failure

How to take part

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

  1. The places running it

    5 sites. 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

  • ICS Maugeri - Istituto di Bari

    RECRUITING

    Bari, BA, 70124, Italy

  • ICS Maugeri - Istituto di Milano

    RECRUITING

    Milan, MI, 20138, Italy

  • ICS Maugeri - Istituto di Pavia

    RECRUITING

    Pavia, PV, 27100, Italy

  • ICS Maugeri - Istituto di Veruno

    RECRUITING

    Veruno, 28013, Italy

  • ICS Maugeri Torino

    RECRUITING

    Torino, TO, 10124, Italy

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