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Heart MRI breakthrough: new scan could replace needle biopsy for rare heart disease

NCT ID NCT04862273

Diagnosis Sponsor: University of Leipzig 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested whether a special type of heart MRI, called T1 mapping, can accurately diagnose cardiac amyloidosis—a condition where abnormal proteins build up in the heart muscle. Researchers studied 112 older adults with heart failure and thickened heart walls. They compared the MRI results to standard tests like a heart biopsy or a special scan. If T1 mapping proves reliable, it could offer a safer, non-invasive way to diagnose this serious condition.

What this could mean

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

Active substance
Native T1 cardiac magnetic resonance imaging (CMR)
What this could lead to
If successful, this MRI technique could become a faster, non-invasive way to diagnose cardiac amyloidosis, reducing the need for biopsies.
What could go wrong
This is a completed study with 112 participants, so results are preliminary. The technique may not be as accurate as standard methods in all patients, and its usefulness depends on further validation.

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

112 people

The number who actually took part.

Started

Apr 2021

Finished

Dec 2024

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 symptomatic heart failure (NYHA functional class II to IV, LVEF ≥40%), increased left ventricular wall thickness and elevated cardiac biomarkers

Ages

60 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: * Age ≥ 60 years * Symptomatic heart failure (NYHA II-IV) with LVEF ≥40% * Increased LV wall thickness (≥12mm end-diastolic) * NT-proBNP ≥1000pg/mL * Elevated hs-troponin T ≥14ng/L Exclusion Criteria: * Contraindications for CMR * Acute myocarditis * Acute myocardial infarction \<1 month * Severe aortic stenosis and RAISE score \< 2 points

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Conditions

The condition(s) this trial relates to.

advanced heart failure Amyloid Neuropathies, Familial amyloidosis diastolic heart failure heart failure Hypertrophy, Left Ventricular mild heart failure moderate heart failure

As listed by the trial registrant

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

Cardiac amyloidosis Heart failure nyha class II Heart failure nyha class III Heart failure nyha class IV Heart failure with mid range ejection fraction Heart failure with preserved ejection fraction Hypertrophy, left ventricular

Contacts and locations

Locations

  • University of Leipzig

    Leipzig, Saxony, 04103, Germany

More trials for these conditions

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