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A simple heart scan may unmask a hidden cause of heart failure

NCT ID NCT05577819

Diagnosis Sponsor: Massachusetts General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time

Summary

This study tests whether a cardiac imaging technique called a PYP scan can detect transthyretin amyloidosis in people aged 65 and older who have heart failure with preserved ejection fraction, also known as diastolic heart failure. The researchers will scan 515 participants to see how often this protein buildup occurs and whether certain clues can predict it. The goal is to identify amyloidosis earlier so patients can start treatment sooner.

What this could mean

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

Active substance
99mTc-pyrophosphate scintigraphy (PYP scan), a cardiac imaging test using a radioactive tracer to detect amyloid deposits in the heart
What this could lead to
If the scan proves reliable, doctors could diagnose transthyretin amyloidosis earlier in heart failure patients, allowing timely treatment and better outcomes.
What could go wrong
The trial is a single-center diagnostic study, so results may not apply broadly. The scan may miss some cases or be less accurate than hoped, and it involves a small amount of radiation.

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

About 515 people

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

Started

Oct 2020

Expected to finish

Dec 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.

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: * Patients with a confirmed diagnosis of HFpEF. * Age ≥65 years old Exclusion Criteria: * End stage chronic kidney disease on dialysis (CKD stage 5 as defined as eGFR \<15mL/min) * no history of HFrEF (LVEF\<40%) with the exception of low LVEF in the setting of acute decompensation, AF RVR, ACS/MI, etc * Negative 99mTc-pyrophosphate scan within a year * Unable to lie down for 15 minutes for the 99mTc-pyrophosphate scan * Known diagnosis of amyloidosis * Severe valvular heart disease that is uncorrected (moderate to severe is considered exclusionary)

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Conditions

The condition(s) this trial relates to.

amyloidosis diastolic heart failure familial amyloid neuropathy heart failure

As listed by the trial registrant

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

Amyloidosis Heart failure Heart failure, diastolic Transthyretin amyloidosis

How to take part

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  1. The places running it

    1 site. 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

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

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