Clinical trial

Screening for Cardiac Amyloidosis With Nuclear Cardiology for Minority Populations

Name
AAAS4054
Description
In this study, the investigators will recruit 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 will also explore differences in genetics and sex as they relate to heart failure disease progression in cardiac amyloidosis.
Trial arms
Trial start
2019-05-15
Estimated PCD
2024-06-01
Trial end
2024-06-01
Status
Recruiting
Treatment
99mTc-PYP or 99m Tc-HDP
10-25 mCi of 99mTc-PYP (or 99m Tc-HDP) will be administered intravenously and imaging will be performed after 3 hours.
Arms:
Blacks/Hispanics with Heart Failure
Other names:
Technetium-99m-Pyrophosphate or Technetium-99m-HydroxyMethyleneDiphosphonate
Size
800
Primary endpoint
Prevalence of Transthyretin Cardiac Amyloidosis in Caribbean Hispanics and Blacks with heart failure (HF)
5 years
Eligibility criteria
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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Participants in this study will provide samples of blood and urine which will be analyzed for specific biomarkers and stored for possible future research.'}, 'enrollmentInfo': {'count': 800, 'type': 'ESTIMATED'}}
Updated at
2024-04-04

1 organization

1 product

2 indications

Organization
Mathew S. Maurer
Product
99mTc-PYP