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NCT03812172Completed

Screening for Cardiac Amyloidosis With Nuclear Imaging for Minority Populations

Screening for Cardiac Amyloidosis With Nuclear Cardiology for Minority Populations

Source: ClinicalTrials.gov · Last updated 19 Nov 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
646 (actual)
First submitted
10 Jan 2019
Start date
15 May 2019
Primary completion date
12 Jun 2024
Lead sponsor
Mathew S. Maurer, MD
NCT number
NCT03812172

What you commit to

  • Study type: Observational
  • Participants enrolled: 646
  • From 15 May 2019 to the primary completion date, 12 Jun 2024
  • 4 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior liver or heart transplantation.
  • Expected use of continuous intravenous inotropic therapy in the next 6 months.

Other illness

  • 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.
  • Impairment from stroke, injury or other medical disorder that precludes participation in the study.
  • Disabling dementia or other mental or behavioral disease.

Lab values

  • Chronic kidney disease with eGFR \<15 mL/min/1.73 m2 or ESRD.

Other

  • Primary amyloidosis (AL) or secondary amyloidosis (AA).
  • Ventricular assist device or anticipated within the next 6 months.
  • Enrollment in a clinical trial not approved for co-enrollment.
  • High risk for non-adherence as determined by screening evaluation.
  • Inability or unwillingness to comply with the study requirements.
  • Weight \>350 lb.
  • Nursing home resident.
  • Other reason that would make the subject inappropriate for entry into this study.

Who the study is looking for

  • 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.

Age in the registry: 60 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Boston Medical Center/Boston University Medical Center
Coordinator of this site? Confirm its status
BostonUnited StatesUnknown status
Yale University/Yale New Haven Medical Center
Coordinator of this site? Confirm its status
New HavenUnited StatesUnknown status
Columbia University Irving Medical Center
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
Harlem Hospital
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.