Heart screening study reveals hidden amyloidosis in minorities

NCT ID NCT03812172

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study screened 646 elderly Black and Hispanic patients with heart failure to find out how many have cardiac amyloidosis, a condition where abnormal proteins build up in the heart. Researchers used a special heart scan and blood tests to detect the disease. The goal was to learn how common it is in these groups and explore links to genetics and sex.

What this could mean

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

Active substance
Technetium-99m-Pyrophosphate or Technetium-99m-HydroxyMethyleneDiphosphonate (radioactive tracer for imaging)
What this could lead to
If successful, this could show that screening high-risk minority groups with heart imaging helps detect cardiac amyloidosis earlier, leading to better management.
What could go wrong
This is a completed screening study, not a treatment trial. It only measures how common the condition is, so it won't directly improve health outcomes.

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

646 people

The number who actually took part.

Started

May 2019

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

Blacks and Caribbean Hispanics with heart failure not primarily due to ischemic heart disease or valvular disease.

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: 1. Black or Hispanic of Caribbean origin. 2. Age ≥ 60 years. 3. Diagnosis of heart failure, confirmed by one of two methods: 1. Modified criteria utilized by Rich et al. which include a history of acute pulmonary edema or the occurrence of at least two of the following that improved with diuretic therapy without another identifiable cause: dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, bilateral lower extremity edema or exertional fatigue, and 2. National Health and Nutrition Examination Survey (NHANES) congestive heart failure (CHF) criteria with a score ≥3. 4. Left ventricular septal OR inferolateral wall thickness ≥12 mm by echocardiography. 5. Left ventricular Ejection fraction \>30% by echocardiography. 6. Able to understand and sign the informed consent document after the nature of the study has been fully explained. Exclusion Criteria: 1. Primary amyloidosis (AL) or secondary amyloidosis (AA). 2. Prior liver or heart transplantation. 3. Active malignancy or non-amyloid disease with expected survival of less than 1 year. 4. Heart failure, in the opinion of the investigator, primarily caused by severe left-sided valve disease. Note: if valve was repaired, subject may be considered as no longer with severe valve disease.Heart failure, in the opinion of the investigator, primarily caused by either valve disease or ischemic heart disease. 5. Heart failure, in the opinion of the investigator, primarily caused by ischemic heart disease. 6. Ventricular assist device or anticipated within the next 6 months. 7. Impairment from stroke, injury or other medical disorder that precludes participation in the study. 8. Disabling dementia or other mental or behavioral disease. 9. Enrollment in a clinical trial not approved for co-enrollment. 10. Expected use of continuous intravenous inotropic therapy in the next 6 months. 11. High risk for non-adherence as determined by screening evaluation. 12. Inability or unwillingness to comply with the study requirements. 13. Chronic kidney disease with eGFR \<15 mL/min/1.73 m2 or ESRD. 14. Weight \>350 lb. 15. Nursing home resident. 16. Other reason that would make the subject inappropriate for entry into this study.

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Conditions

The condition(s) this trial relates to.

Amyloid Neuropathies, Familial heart failure wild type ATTR amyloidosis

As listed by the trial registrant

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

Contacts and locations

Locations

  • Boston Medical Center/Boston University Medical Center

    Boston, Massachusetts, 02118, United States

  • Columbia University Irving Medical Center

    New York, New York, 10032, United States

  • Harlem Hospital

    New York, New York, 10037, United States

  • Yale University/Yale New Haven Medical Center

    New Haven, Connecticut, 06519, United States

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