Status:
COMPLETED
Screening for Cardiac Amyloidosis With Nuclear Imaging for Minority Populations
Lead Sponsor:
Mathew S. Maurer, MD
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Boston Medical Center
Conditions:
Amyloid Cardiomyopathy, Transthyretin-Related
Eligibility:
All Genders
60+ years
Brief 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 sensitiv...
Detailed Description
Heart failure with preserved ejection fraction (HFpEF) disproportionately afflicts older Black and Hispanic Americans. Transthyretin cardiac amyloidosis (ATTR CA) is caused by myocardial deposition of...
Eligibility Criteria
Inclusion
- 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
- 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 \<15 mL/min/1.73 m2 or ESRD.
- Weight \>350 lb.
- Nursing home resident.
- Other reason that would make the subject inappropriate for entry into this study.
Key Trial Info
Start Date :
May 15 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 13 2024
Estimated Enrollment :
646 Patients enrolled
Trial Details
Trial ID
NCT03812172
Start Date
May 15 2019
End Date
December 13 2024
Last Update
November 19 2025
Active Locations (4)
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1
Yale University/Yale New Haven Medical Center
New Haven, Connecticut, United States, 06519
2
Boston Medical Center/Boston University Medical Center
Boston, Massachusetts, United States, 02118
3
Columbia University Irving Medical Center
New York, New York, United States, 10032
4
Harlem Hospital
New York, New York, United States, 10037