N/A
N=646
Screening for Cardiac Amyloidosis With Nuclear Imaging for Minority Populations
Amyloid Cardiomyopathy, Transthyretin-Related
Bottom Line
View on ClinicalTrials.gov: NCT03812172 ↗Enrolled (actual)
646
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcome: Primary: Prevalence of Transthyretin Cardiac Amyloidosis (ATTR-CA) in Cohort of Caribbean Hispanics and Blacks With Heart Failure (HF) — 7.8; 0 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- 99mTc-PYP or 99m Tc-HDP (Drug)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Mathew S. Maurer, MD
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Prevalence of Transthyretin Cardiac Amyloidosis (ATTR-CA) in Cohort of Caribbean Hispanics and Blacks With Heart Failure (HF) |
7.8; 0 | — |
| PRIMARY Age Distribution of ATTR Cardiac Amyloidosis |
3.42; 0; 14.04; 0 | — |
| PRIMARY Sex Distribution of ATTR Cardiac Amyloidosis |
9.7; 0; 6; 0 | — |
| PRIMARY Self-Identified Hispanic Ethnicity Distribution of ATTR Cardiac Amyloidosis. |
4.4; 0 | — |
| PRIMARY ATTR Type Distribution of Cardiac Amyloidosis |
19; 0; 24; 0 | — |
Summary
In this study, the investigators recruited a cohort of elderly Black and Hispanic patients with heart failure to define the number of patients who have cardiac amyloidosis by utilizing highly sensitive heart imaging and blood tests. The investigators also explored differences in genetics and sex as they relate to heart failure disease progression in cardiac amyloidosis.
Eligibility Criteria
Inclusion Criteria
- Black or Hispanic of Caribbean origin.
- Age ≥ 60 years.
- Diagnosis of heart failure, confirmed by one of two methods:
- 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
- National Health and Nutrition Examination Survey (NHANES) congestive heart failure (CHF) criteria with a score ≥3.
- Left ventricular septal OR inferolateral wall thickness ≥12 mm by echocardiography.
- Left ventricular Ejection fraction >30% by echocardiography.
- Able to understand and sign the informed consent document after the nature of the study has been fully explained.
Exclusion Criteria
- Primary amyloidosis (AL) or secondary amyloidosis (AA).
- Prior liver or heart transplantation.
- Active malignancy or non-amyloid disease with expected survival of less than 1 year.
- 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.
- Heart failure, in the opinion of the investigator, primarily caused by ischemic heart disease.
- Ventricular assist device or anticipated within the next 6 months.
- Impairment from stroke, injury or other medical disorder that precludes participation in the study.
- Disabling dementia or other mental or behavioral disease.
- Enrollment in a clinical trial not approved for co-enrollment.
- Expected use of continuous intravenous inotropic therapy in the next 6 months.
- High risk for non-adherence as determined by screening evaluation.
- Inability or unwillingness to comply with the study requirements.
- Chronic kidney disease with eGFR 350 lb.
- Nursing home resident.
- Other reason that would make the subject inappropriate for entry into this study.
Data sourced from ClinicalTrials.gov (NCT03812172). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.