Screening for Cardiac Amyloidosis With Nuclear Imaging for Minority Populations
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.
Conditions:
🦠 Amyloid Cardiomyopathy, Transthyretin-Related
🗓️ Study Start (Actual) 15 May 2019
🗓️ Primary Completion (Estimated) June 2024
✅ Study Completion (Estimated) June 2024
👥 Enrollment (Estimated) 800
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 New Haven, Connecticut, United States
📍 Boston, Massachusetts, United States
📍 New York, New York, United States
📍 New York, New York, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 60 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 10 January 2019
  • First Submitted that Met QC Criteria 17 January 2019
  • First Posted 23 January 2019

Study Record Updates

  • Last Update Submitted that Met QC Criteria 3 April 2024
  • Last Update Posted 4 April 2024
  • Last Verified April 2024