Heart screening study reveals hidden amyloidosis in minorities
NCT ID NCT03812172
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.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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646 people
The number who actually took part.
- Started
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May 2019
- Finished
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Dec 2024
- Lead sponsor
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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
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60 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Boston Medical Center/Boston University Medical Center
Boston, Massachusetts, 02118, United States
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Columbia University Irving Medical Center
New York, New York, 10032, United States
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Harlem Hospital
New York, New York, 10037, United States
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Yale University/Yale New Haven Medical Center
New Haven, Connecticut, 06519, United States
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