Screening for Cardiac Amyloidosis With Nuclear Imaging for Minority Populations (NCT03812172) | Clinical Trial Compass
CompletedNot Applicable
Screening for Cardiac Amyloidosis With Nuclear Imaging for Minority Populations
United States646 participantsStarted 2019-05-15
Plain-language 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.
Who can participate
Age range60 Years
SexALL
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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.
What they're measuring
1
Prevalence of Transthyretin Cardiac Amyloidosis (ATTR-CA) in Cohort of Caribbean Hispanics and Blacks With Heart Failure (HF)
Timeframe: Study Participation of One Year
2
Age Distribution of ATTR Cardiac Amyloidosis
Timeframe: Study Participation of One Year
3
Sex Distribution of ATTR Cardiac Amyloidosis
Timeframe: Study Participation of One Year
4
Self-Identified Hispanic Ethnicity Distribution of ATTR Cardiac Amyloidosis.