Screening for Cardiac Amyloidosis With Nuclear Imaging for Minority Populations (NCT03812172) | Clinical Trial Compass
CompletedNot Applicable
Screening for Cardiac Amyloidosis With Nuclear Imaging for Minority Populations
United States646 participantsStarted 2019-05-15
Plain-language 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 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.
Who can participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Prevalence of Transthyretin Cardiac Amyloidosis (ATTR-CA) in Cohort of Caribbean Hispanics and Blacks With Heart Failure (HF)
Timeframe: Study Participation of One Year
2
Age Distribution of ATTR Cardiac Amyloidosis
Timeframe: Study Participation of One Year
3
Sex Distribution of ATTR Cardiac Amyloidosis
Timeframe: Study Participation of One Year
4
Self-Identified Hispanic Ethnicity Distribution of ATTR Cardiac Amyloidosis.
. 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 criteria
. 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.