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Stress echo could unmask hidden heart valve disease in amyloidosis patients

NCT ID NCT06372301

Diagnosis Sponsor: Steen Hvitfeldt Poulsen 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looked at 15 patients with a rare heart condition called wild-type transthyretin amyloid cardiomyopathy (ATTRwt) who also had signs of aortic stenosis. Researchers used dobutamine stress echocardiography—a test that uses a drug to make the heart pump harder while imaging it—to see if it could accurately measure the severity of the valve narrowing. The goal was to compare this non-invasive method with the standard invasive measurement to improve diagnosis and avoid unnecessary procedures.

What this could mean

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

Active substance
Dobutamine (a heart-stimulating drug used during stress echocardiography)
What this could lead to
If successful, this could provide a reliable, non-invasive way to diagnose severe aortic stenosis in patients with ATTR amyloidosis, reducing the need for invasive procedures.
What could go wrong
This is a small, completed study with only 15 participants, so results may not apply to everyone. The test may still be less accurate than the gold-standard invasive measurement.

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.

Participants

15 people

The number who actually took part.

Started

Apr 2024

Finished

Mar 2026

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

65 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. ATTRwt, diagnosis confirmed by 99mtc-3,3-Diphosphono-1,2-Propanodicarboxylic Acid (DPD) scintigraphy, genetic testing, and/or endomyocardial biopsy. 2. Symptomatic patients (New York Heart Association \> class I) treated with loop diuretics. 3. LF/LG AS: Defined as, aortic valve area ≤ 1 cm2 and mean gradient \< 40 mmHg, and SVI ≤35 ml/m2. 4. Age ≥ 65 years. 5. Oral and written informed consent. Exclusion Criteria: 1. Other significant valvular disease. 2. Known severe coronary artery diseases: left main stem stenosis or 3-vessel disease, or recent acute myocardial infarction (\< 4 weeks). 3. Contraindications to the use of dobutamine: Known allergy to dobutamine or sulfite, phaeochromocytoma or ventricular tachycardia (VT).

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis wild type ATTR amyloidosis

As listed by the trial registrant

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

Aortic stenosis Transthyretin amyloid cardiomyopathy

Contacts and locations

Locations

  • Department of Cardiology, Aarhus University Hospital

    Aarhus, 8200, Denmark

More trials for these conditions

Other studies related to the condition(s) this trial covers.