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
- Diseases
- Amyloidosis, Heart failure
- 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
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Boston Medical Center/Boston University Medical Center Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Yale University/Yale New Haven Medical Center Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| Columbia University Irving Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Harlem Hospital Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.